Dr. Thanuja Kularatne

For your Invisalign treatment, trust Dr. Thanuja Kularatne and her team at Mermaid Dental. With their expertise, you’ll receive an accurate diagnosis, precise aligner fittings, and personalized care, ensuring optimal results and a seamless treatment experience.

Dr. Thanuja Kularatne, owner of Mermaid Dental, says, “At Mermaid Dental, we use advanced technology and tailored treatment plans to create stunning smiles with Invisalign. Our knowledgeable team delivers precise, personalized care for exceptional results.”

At Mermaid Dental, our dedicated team offers ongoing professional support throughout your Invisalign journey, with regular check-ups and adjustments to keep your treatment on track and tailored to your evolving dental needs. Invisalign® treatment includes advanced digital planning to map out each stage of tooth movement, ensuring custom-designed aligners for optimal results.

Sonya G. says, “I love Mermaid Dental! Dr. K and her team are fantastic, providing exceptional customer service. They take great care to ensure you’re comfortable before starting any treatment.”

Transform your smile with Invisalign® at Mermaid Dental. Contact us today at (512) 593-6342 or visit dentistinsanmarcos.com to schedule your consultation.

Our team is ready to guide you through every step of your journey toward a beautifully aligned smile.

iTero Design Suite offers doctors an intuitive way to design for in-practice 3D printing of models, bite splints, and restorations, leveraging the power of exocad CAD/CAM software with simplified doctor and staff-friendly design applications. (Photo: Business Wire)

The latest software innovation is designed to help doctors boost their practice efficiency and elevate patient experiences by shortening time to treatment through an intuitive way to design for in-practice 3D printing. The iTero Design Suite enhances the Align Digital Platform, which provides an innovative portfolio of customer-focused technologies that enable seamless end-to-end workflows for dental professionals.

“I’m excited to be working with the iTero Design Suite. I was looking for in-practice design software that my team and I could use. The workflow is fast and efficient. We can easily design restorations, hard splints, models, and mockups to show patients the possibilities of cosmetic dentistry,” said Dr. Steven Glassman, a cosmetic dentist based in New York City and a speaker for Align Technology who participated in the limited market release.

“We have seen growing interest in 3D printing technology from our customers, and bringing the iTero Design Suite to market reflects our commitment to offering our customers the digital transformation solutions they need to enhance practice efficiency and patient experiences through powerful technology,” said Karim Boussebaa, Align Technology executive vice president and managing director, iTero scanner and services business.

Tillmann Steinbrecher, CEO of exocad, added: “With the iTero Design Suite, doctors will benefit from a flexible solution that enables seamless workflows for in-practice production using exocad’s innovative software.”

iTero Design Suite is now available through an early access program. Doctors using an iTero scanner can submit their interest via their scanner or the MyiTero portal. The software is expected to be available later this year.*

*Available in selected markets

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 266 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 27 years, Align has helped doctors treat over 18.2 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Dr. Sandra Tai’s patient independently inserting Invisalign® Palatal Expander. (Photo: Business Wire)

The Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during treatment of patients.

“The Invisalign Palatal Expander is an example of our continuous commitment to innovation by advancing digital orthodontics and delivering products with greater efficiency for doctors and provide better treatment experiences for patients and their parents,” said Raj Pudipeddi, Align Technology chief marketing officer, executive vice president, and managing director, Asia Pacific. “We are delighted to introduce the Invisalign Palatal Expander system, Align’s first directly fabricated orthodontic appliance, to the Asia Pacific region.”

The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor. Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero intraoral digital scan. A palatal expansion treatment plan and device design are then developed using Align’s proprietary AI-driven orthodontic software.

Combined with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment for young patients. Phase 1 treatment is traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted – typically at ages 6 through 10. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion*.

“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align Technology senior vice president, Global Clinical. “Together with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children. The addition of mandibular advancement features to Invisalign aligners also provides doctors with more options for treating skeletal and dental jaw imbalances and bite correction for their growing patients during their teenage years.”

“We are excited to present the Invisalign Palatal Expander system, a significant advancement in the field of digital orthodontics, to our doctor customers in Australia and New Zealand,” said Jonathan Primmer, Align Technology vice president, and managing director for Australia and New Zealand. “With the increasing demand for orthodontic treatment among children and teenagers in Australia and New Zealand, the launch of the Invisalign Palatal Expander system allows us to offer a more comprehensive early interceptive treatment solution in conjunction with Invisalign First, alleviating the most complex challenges with palatal expansion while providing an exceptional patient experience that is both comfortable and supports proper oral hygiene.”

The Invisalign Palatal Expander System is now available in Australia and New Zealand. It is expected to be available in other APAC markets pending regulatory approvals starting in 2024.

*Data on File at Align Technology, as of June 2021.

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 256 thousand doctor customers worldwide and are key to accessing Align’s 600 million consumer market opportunity worldwide.

Over the past 26 years, Align has helped doctors treat over 17 million patients worldwide with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists, and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com.au. For additional information about the iTero digital scanning system, please visit www.itero.com.au.

For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Invisalign, iTero, exocad, Align, and Align Digital Platform are trademarks of Align Technology, Inc.

About The Invisalign Palatal Expander System

The Invisalign Palatal Expander System is a modern, innovative direct 3D printed orthodontic appliance designed based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch, palate) with primary, mixed (primary and permanent), or permanent dentition during interceptive treatment such as Phase 1 treatment and orthodontic or orthopedic treatment in children, adolescents, or adults in conjunction with surgery or other interventions when necessary.

Devices are 3D printed and are manufactured based on digital scan data from commercially available iTero® intraoral scanners offered by Align Technology, Ltd. The devices are removable and make it easier for patients to maintain oral hygiene compared to traditional palatal appliances; manufactured to custom fit each patient’s anatomy for optimal comfort and aesthetics, expanders fit comfortably in the patient’s mouth and are changed daily (no screw required).

The System is comprised of Invisalign Palatal Expanders (active expansion, each stage comes with a programmed expansion of 0.25mm/day, changed daily or as per doctor’s discretion) and Invisalign Palatal Holders (copy of the last stage ​of the expansion designed to hold the maxilla post-active expansion phase, changed every 2-4 weeks as directed by the treating doctor), Invisalign Attachment Templates and proprietary 3D shape generation software. These products are not available for purchase by the general public.

However, the products are available for purchase from Invisalign trained dentists and orthodontists.

A class action lawsuit has been filed against Align Technology, Inc. (“Align” or Defendant) by two dental practices, alleging that Align engaged in anticompetitive conduct, causing those who directly purchased Invisalign Aligners from Align to pay more than they should have. Align denies these allegations, and the court has not determined whether Align has committed any wrongdoing.

The court has permitted the lawsuit to proceed as a class action on behalf of all individuals or entities in the United States who purchased Invisalign Aligners directly from Align during the period from January 1, 2019, through March 31, 2022 (the “Class Period”). Excluded from the Class are (1) Align, its subsidiaries, affiliate entities, and employees, and (2) all federal or state government entities or agencies.

There is currently no money available, and there is no guarantee that funds will be available in the future. Nevertheless, your legal rights are affected, and you must make a decision now.

LEGAL RIGHTS AND OPTIONS

Do Nothing: Stay in this lawsuit. Await the outcome. Give up certain rights. By taking no action, you will remain a class member in this class action lawsuit. If the Plaintiffs obtain money, either through trial or settlement, you may be eligible to share in that money and will be notified of how to claim your share. If the case proceeds to trial and the Class does not succeed, you will be bound by that judgment. By staying in the Class, you relinquish any rights to individually sue Align for the same legal claims about Invisalign Aligners in this lawsuit.

Exclude Yourself: Opt out of this lawsuit. Forgo the right to share in any money obtained from it. Retain your legal rights. You have the option to request exclusion from this lawsuit. The court will exclude any member who requests exclusion from the Class. This is the only way to preserve any right you have to participate in another potential lawsuit seeking money for legal claims arising from the facts alleged in this lawsuit about Invisalign Aligners. If you wish to opt out, you must submit a written “Request for Exclusion” to the Class Administrator. To be valid, your Request for Exclusion must be postmarked by March 15, 2024, and mailed to: Align Direct Purchaser Antitrust Exclusion Request, c/o Class Administrator, P.O. Box 2418, Portland, OR 97208-2418.

Lawyers must prove the legal claims about Invisalign Aligners against Align at a trial scheduled to begin on May 13, 2024, in the United States District Court for the Northern District of California, Phillip Burton Federal Building & United States Courthouse, 450 Golden Gate Avenue, San Francisco, CA 94102, in Courtroom 4. If money is obtained from Align, and you remain in the Class, you will be notified about how to request a share. There is no guarantee that the Plaintiffs will prevail or that they will receive any money for the Class.

Note: The date and time of the trial may change without further notice to the class.

Please check www.aligndirectpurchaserantitrust.com to confirm that the trial date has not changed.

Have any questions? Visit www.aligndirectpurchaserantitrust.com or call toll-free 1-888-803-3968.

FEATURED IMAGE CREDIT: Arek Socha from Pixabay.

Previously introduced at the Align Technology Investor Day in September 2023, the Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during treatment of patients. The Invisalign Palatal Expander is Align’s first direct 3D printed orthodontic device and provides a safe, comfortable, and clinically effective* alternative to traditional palatal expanders that require manually turning a screw in the device in the mouth daily to achieve expansion.

The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor.** Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero intraoral digital scan. A palatal expansion treatment plan and device design are then developed using Align’s proprietary AI-driven orthodontic software.

Combined with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment for young patients. Phase 1 treatment is traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted—typically at ages 6 through 10. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion***.

“Many parents in my practice have found it challenging to physically turn the screws on traditional palatal expanders,” said Dr. David Walt, an orthodontist in Vaughan, Ontario, and participant in Align’s Invisalign Palatal Expander System limited release program in Canada. “The Invisalign Palatal Expander removes this concern and creates a better overall experience for patients and their parents. Beyond that, there have not been related emergency visits, something that is more common with traditional palatal expanders.”

“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align senior vice president, Global Clinical. “Together with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children. The addition of mandibular advancement features to Invisalign aligners also provides doctors with more options for treating skeletal and dental jaw imbalances and bite correction for their growing patients during their teenage years.”

“The Invisalign Palatal Expander System is a game changer, as it alleviates the most common challenges with palatal expansion, including maintaining proper hygiene, emergency appointments, turning the screw, and the parents’ fear of causing pain to their child in treatment,” said Dr. Sandra Tai, an orthodontist in Vancouver and participant in Align’s Invisalign Palatal Expander System limited release program in Canada. “It’s removable and supports oral hygiene while delivering a clinically effective and comfortable treatment experience for growing patients that achieves high satisfaction rates reported by parents.”

The Invisalign Palatal Expander System is pending pre-market notification 510(k) clearance by the U.S. Food and Drug Administration and is not yet available in the United States. It is expected to be available in other markets pending regulatory approvals starting in 2024.

*Based on a survey in August 2023 in Canada of 10 Invisalign trained orthodontists who participated in the Invisalign Palatal Expander System Technical Design Assessment and have treated at least 1 patient age 6-11 years with IPE. Data on file at Align Technology, Inc. as of October 30, 2023.

**Based on data from a multi-site US IDE (Investigational Device Exemption) clinical study (n=29 subjects, ages 7-10 years) of expansion treatment with Invisalign® Palatal Expanders. Data on file at Align Technology, Inc. as of October 30, 2023

***Data on File at Align Technology, as of June 2021.

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign System, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for approximately 252 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 26 years, Align has helped doctors treat over 16.4 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign System or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Invisalign, iTero, exocad, Align, and Align Digital Platform are trademarks of Align Technology, Inc.

About The Invisalign Palatal Expander System*

The Invisalign Palatal Expander System* is a modern, innovative direct 3D printed orthodontic appliance designed based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch, palate) with primary, mixed (primary and permanent), or permanent dentition during interceptive treatment such as Phase 1 treatment and orthodontic or orthopedic treatment in children, adolescents or adults in conjunction with surgery or other interventions when necessary. Devices are 3D printed and are manufactured based on digital scan data from commercially available iTero® intraoral scanners offered by Align Technology, Ltd. The devices are removable and more hygienic than traditional appliances; manufactured to custom fit each patient’s anatomy for optimal comfort and aesthetics, expanders fit comfortably in the patient’s mouth and changed daily (no screw required).

The System is comprised of Invisalign Palatal Expanders (active expansion, each stage comes with a programmed expansion of 0.25mm/day, changed daily or as per doctor’s discretion) and Invisalign Palatal Holders, (copy of the last stage ​of the expansion designed to hold the maxilla post-active expansion phase, changed every 2-4 weeks as directed by the treating doctor).

Invisalign Outcome Simulator Pro supports a streamlined workflow, making the most of patient chair time. Patient photos are easily captured with the Invisalign Practice App and the scan is taken from the iTero Element Plus Series imaging system. The simulation starts automatically in the background, enabling doctors to continue the consultation using other iTero scanner tools.

Once the simulation is generated, it can be accessed any time from the cloud via your scanner, PC or tablet.

Learn more about the IOSim Pro at iTero.com.

It includes features such as patient enrollment, setup, and review directly on the Invisalign Doctor Site without the need to use separate standalone solutions.

Invisalign Virtual Care AI helps doctors remotely monitor Invisalign treatment progress based on their own pre-approved clinical settings and AI-assisted algorithms for Automatic Assessment calibrated to each doctor’s ClinCheck treatment features. AI-assisted Automated Notifications, based on doctor settings, guide patients to either advance to the next aligner stage if their treatment is tracking well or to stay on their current stage for longer or to contact their doctor if their treatment is not tracking.

Invisalign Virtual Care AI builds on the MedTech Breakthrough award winning Invisalign Virtual Care platform launched in March 2020 during the COVID-19 pandemic to help Invisalign doctors connect with patients remotely through the My Invisalign App to monitor treatment progress, and ensure continuity of care of patients during Invisalign treatment.

It offers several software features to create a seamless and intelligent, single-platform experience. Part of the Invisalign Virtual Care AI solution is the AI-assisted Automated Notifications (Virtual Care 3.0) feature which is a registered medical device in some countries.

“Align is committed to continuous innovation in digital orthodontics and I am very excited about our next generation AI-assisted remote monitoring solution,” said Raj Pudipeddi, Align Technology chief product and marketing officer, executive vice president and managing director, Asia Pacific. “Invisalign Virtual Care AI is the only doctor-directed AI-assisted remote monitoring solution in the market that integrates with the Align Digital Platform, enabling doctors to prioritize Invisalign treatment tracking exceptions. It creates a seamless and intelligent, single-platform experience for Invisalign doctors and their staff through integration with the Invisalign Doctor Site, without the need for a separate portal and login, or expensive third-party workarounds. In addition, since it’s part of the Align Digital Platform and integrated with ClinCheck software, it incorporates attributes from the approved treatment plan into the assessment, such as tooth type, size, shape, etc. Further, it automatically assesses patient-submitted photos through our My Invisalign App, sending instructions back to patients on their smartphone in as little as one hour.”

“Invisalign Virtual Care AI is another great example of how we are using digital technology to connect doctors and their patients to facilitate even greater continuity of care and deliver a streamlined experience,” said Dr. Mitra Derakhshan, Align senior vice president, global clinical. “Aligner fit and seating are important clinical indicators of Invisalign treatment progress tracking and compliance. The AI-assisted Automatic Assessment algorithms measure and highlight aligner spaces, based on doctor approved settings, and AI-assisted Automated Notifications inform patients on actions such as whether to advance to the next stage, stay on their current stage, or contact their doctor for further instructions. These AI-assisted technologies integrated with human confirmation enable practices to prioritize Invisalign treatment tracking exceptions.”

“I initially began using Invisalign Virtual Care at the outset of the COVID-19 pandemic to ensure continuity of care for my Invisalign patients,” said Dr. David R. Boschken, an orthodontist and Align Technology Global Faculty member located in Los Altos, California. “The new AI-assisted algorithms in Invisalign Virtual Care AI have elevated the remote monitoring experience for me and my patients. Automatic Assessment provides me with objective measurement of aligner spaces, the single most important indicator of Invisalign treatment tracking in my practice, while Automated Notifications advise patients of their progress in less than one hour, which in turn enables me to focus on treatment tracking exceptions. And since Invisalign Virtual Care AI is integrated with the Align Digital Platform, I don’t have to log into a separate portal or use third party remote monitoring services. This efficiency has enabled me to save chair time and expand the geographic reach of my practice. It has given me the confidence to enroll over 1,000 of my Invisalign patients into Invisalign Virtual Care AI, from teens and young adults to seniors – this is the new way to follow Invisalign treatments for orthodontic practices.”

“Invisalign Virtual Care AI has transformed how I follow the treatment progress of my Invisalign patients,” said Dr. Jan Einfeldt, a GP dentist located in Kent, United Kingdom. “Tooth movement using Invisalign clear aligners is often the first step in a smile makeover, which may require a combination of procedures such as implants, veneers and crowns, so it is critical to keep treatment progress on track. By using my pre-approved preferences and automatically integrating attributes of my approved ClinCheck treatment plan, such as tooth type, shape, size, pontics, etc., the AI algorithms help determine aligner fit and advise patients to advance to the next aligner tray or stay on their current tray for longer to ensure the desired movements take effect. Invisalign Virtual Care AI is now the gold standard of follow up across all procedures in my practice that include Invisalign treatment.”

AI-Assisted Remote Monitoring Fully Integrated with the Align Digital Platform

Invisalign Virtual Care AI is integrated with the Align Digital Platform, which includes the Invisalign Doctor Site, ClinCheck treatment plans, and the My Invisalign App. No separate portal or login is required since remote monitoring is managed directly on the Invisalign Doctor Site, which benefits doctors and their staff.

Similarly, patients can use their My Invisalign App without the need to download a separate app for remote monitoring.

• AI-Assisted Photo Capture: Easy capture of clinically relevant photos via the My Invisalign App for patients with a next-generation user interface and intelligent real-time photo guidance. Patients send photos with every aligner change and receive progress notifications on their My Invisalign App. No separate remote monitoring app is required.
• AI-Assisted Automatic Assessment*: Automatic assessment measures and highlights the size of aligner spaces based on doctor settings.
  • Objective and doctor-directed: AI uses each doctor’s settings to objectively measure aligner spaces. Doctors can customize settings at a clinic level or for individual patients.
  • Personalized and integrated with ClinCheck treatment plan attributes: Virtual Care AI assessment automatically integrates tooth type, shape, and size from the doctor-approved ClinCheck treatment plan.
  • Tooth-specific detail: Aligner spaces are measured and highlighted individually for each tooth. This enables doctors to quickly hone-in on problem areas where teeth do not correctly fit into the tray. Any exceptions to treatment progress, such as aligner fit or a tooth that is not moving as expected are flagged for doctor review, helping ensure patient treatments are being monitored between in-office visits.
• AI-Assisted Automated Notification: Automated Notifications are delivered to patients through the My Invisalign App in ~1 hour based on doctor settings. Patients are instructed to advance to the next tray if their treatment is tracking well, or to stay on their current aligner or to contact their doctor if their treatment is off track. Automated notifications enable practices to prioritize patients review.

The Invisalign Virtual Care AI remote monitoring solution is in active global rollout to Invisalign trained doctors with availability beginning in certain markets in APAC, EMEA and Americas. Doctors should check with their Align sales representative for information specific to their market and product availability.

For more information, they can also visit the ‘Virtual Care’ tab on their Invisalign Doctor Site.

*AI assessment results are reviewed by Align-trained personnel prior to Automated Notification being sent to ensure assessment is consistent with doctor’s settings.

About Align Digital Platform

The Align Digital Platform is an integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end experience and workflow that connects users.

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign® system, the most advanced clear aligner system in the world, iTero® intraoral scanners and services, and exocad® CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 212 thousand doctor customers and is key to accessing Align’s 500 million consumer market opportunity worldwide.

Over the past 25 years, Align has helped doctors treat over 13.4 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners.

Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com.

For additional information about the iTero digital scanning system, please visit www.itero.com.

For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced the new iTero Workflow 2.0 software release with advanced features that provide enhanced intraoral image sharpness for clearer hard and soft tissue details to aid in treatment diagnosis, while also driving practice efficiency, patient engagement, and a more seamless end-to-end digital treatment experience for doctors and their patients.

“Align’s commitment to innovation in digital orthodontics and restorative dentistry reflects our $250 million annual investment in technology to develop products and services that provide doctors and their patients with a great treatment outcome and seamless experience through the Align digital platform,” said Yuval Shaked, Align SVP and MD of the iTero systems and services business. “Our new iTero Workflow 2.0 software features were developed to simplify and streamline a doctor’s daily routine and increase practice efficiency. From a faster, all-in-one scan with enhanced visualisation capabilities to improved patient communication, including the ability to capture, annotate and then share Invisalign simulations or restorative treatment plans digitally, these new features provide doctors with the ability for better clinical diagnosis and help patients better understand their oral health conditions and the proposed treatment options.”

The newly released iTero Workflow 2.0 software features include:

·               Faster scanning: Enables a faster and smoother all-in-one scan for maximum efficiency with 20% less waiting for processing time on the iTero Element Plus Series scanners1 and 50% faster movement and 25% faster rotation during scanning2 for efficient daily use and ease of learning on all iTero Element scanners. 

·               Improved visualisation: The integrated 3D intraoral camera included in the iTero Element 5D Plus imaging system provides enhanced sharpness and improved image quality powered by advanced AI capabilities to deliver clearer soft and hard tissue details to support diagnosis3. In addition, the enhanced capabilities allow clinics to efficiently use intraoral scan images in place of traditional intraoral photos as they can capture multiple intraoral images at different angles automatically with one scan.

·               Next level patient communication tools: The new Snapshot tool and iTero Scan Report provide doctors and their staff with the ability to capture information such as Invisalign Outcome Simulator projections and share it digitally with their patients, allowing patients to make more confident decisions – in the dental chair or at home – which may lead to higher treatment acceptance.

“I am already experiencing meaningful difference with the new iTero software features and have seen significantly reduced scan times,” said Dr. Olivier Boujenah, a dentist in France who participated in the limited market release. “The intraoral images are much sharper, and my patients are impressed by the details and clarity, which leads them to ask more questions about treatment options. Being able to send digital files with patients when they leave the office through the iTero Scan Report keeps our conversation going even after they are home, and I already see this capability helping with patient acceptance.”

iTero Workflow 2.0 software features are being rolled out regionally and are expected to be available in all markets where the iTero Element Plus imaging systems are available.  The iTero Element Plus Series is available in the United States, Canada, European Union, Norway, Switzerland, United Kingdom, Australia, New Zealand, Japan, Singapore, Hong Kong, and India with availability expected in other markets throughout 2021 and 2022. Software features will vary by scanner. Discover more at https://bit.ly/2ROw0fD.

 Simplified workflow through new iTero Element 5D auto-upload functionality

The company also announced the launch of a new iTero Element 5D imaging system auto-upload of intraoral photos for Invisalign case submissions. This new functionality eliminates steps and streamlines Invisalign case submissions with intraoral color scan images that can be used in place of traditional intraoral photos.

The iTero Element 5D imaging system wands are designed with advanced technology, including an intraoral camera, that enables the doctor to scan, capture and auto convert the scan into 2D color photos.   This enhanced capability provides doctors the option to automatically populate the five required images in the prescription form in the Invisalign Doctor Site (IDS) with 2D color scan photos. Currently, the Invisalign prescription form requires at least five intraoral photos upon submission, taken with Invisalign Photo Uploader (IPU) or a digital camera.   This new auto upload functionality will be available in all markets where the iTero Element 5D imaging systems are sold.

“The iTero Element 5D is a milestone in the development and modernisation of my practice” – said Dr. Joanna Vorhauser, Invisalign dentist from Germany. “The technology does not only impress our team, but also our patients and supports us in our communication with them: Now our patients can see their teeth and oral health from our perspective. The visualisation tools are also great for educational discussions and documentation. With the availability of the 5D auto upload functionality, we can now submit Invisalign case prescription without the need for intraoral photos, which makes the upload to the Invisalign Doctor Site is even faster. These improvements are also much more convenient for patients, and my assistant doesn’t have to worry about the quality of the images.”

1.     Data on file, as of December 22, 2020.

2.     Compared with previous software versions. Data on file at Align Technology, as of March 29, 2021.

3.     Only available on iTero Element 5D Plus imaging systems (full and Lite software configurations).

*iTero Element 5D Imaging systems include iTero Element 5D and iTero Element 5D Plus series scanners.

About Align Technology, Inc.

Align Technology designs, manufactures and offers the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat over 10.9 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit http://www.exocad.com.

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“Optimized for Invisalign Aligners and Vivera Retainers Powered by Ultradent’s Opalescence Tooth Whitening Systems”

Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced an exclusive supply and distribution agreement with Ultradent Products Inc., a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide.

As part of the multi-year agreement, Align will offer Invisalign trained doctors an exclusive professional whitening system with the leading Opalescence PF whitening formula from Ultradent, optimized for use with Invisalign clear aligners and Vivera retainers. The system will carry the co-branded name of ‘Invisalign Professional Whitening System – powered by Opalescence’ and will offer the same great whitening outcomes and streamlined practice experience dental professionals expect from the Opalescence PF product during active tooth movement with Invisalign aligners, as well as during passive retention using Vivera retainers. The Invisalign Professional Whitening System will be commercially available globally in 2022.

“A brighter, whiter smile is an important part of the Invisalign patient journey. In fact, a survey of North American Invisalign practices (1) shows that half of their patients ask for teeth whitening during or after they complete Invisalign treatment,” said Raj Pudipeddi, Align Technology chief product and marketing officer, and SVP and managing director of the Asia Pacific Region. “We believe that by providing an all-in-one solution that combines a leading teeth-whitening system with the most advanced clear aligner system in the world, we enable Invisalign trained doctors to enhance their patients’ treatment experience with a seamless workflow that also enables practice efficiency and growth. We’re very excited to partner with Ultradent to offer the first professional whitening system optimized for use with Invisalign clear aligners and Vivera retainers. Invisalign system trained doctors can use Opalescence PF for in-office teeth whitening treatment and for doctor supervised at-home whitening.”

“We’re honored to partner with Align to make the top professional teeth whitening products available to more clinicians and patients around the world,” said Ultradent President and CEO Dirk Jeffs. “Providing Align with teeth whitening products, ideal for use with Invisalign aligners and Vivera retainers, is a considerable step toward our mission of improving oral health globally and we look forward to pursuing this mission together.”

“Many of my patients would like whiter teeth as well as a straighter smile,” said Dr. Brian Amy, an orthodontist and Align Faculty member practicing in Oklahoma City. “The new Invisalign Professional Whitening System allows me to provide both simultaneously using the brands I trust.”

“After testing this system in my practice, I can confirm that the Invisalign Professional Whitening System is easy to administer and offers a great patient experience by combining whitening with Invisalign aligners or Vivera retainers,” said Dr. Jennifer Bell, a restorative and cosmetic dentist and Align GP Advisory Board Member practicing in Holly Springs, North Carolina. “The simple ordering mechanism minimizes burden on my practice to store and manage whitening products, while providing the brighter, whiter smiles we have come to expect from the Opalescence PF product.”  

Ultradent is an ISO13485 certified facility and will manufacture the products according to those standards.

(1) 2017 online survey of Invisalign doctors, data on file at Align Technology.

About Align Technology, Inc.

Align Technology designs, manufactures and offers the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat approximately 10.9 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

About Ultradent Products, Inc.

Ultradent Products, Inc., is a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s vision is to improve oral health globally. Ultradent also works to improve the quality of life and health of individuals through financial and charitable programs. For more information about Ultradent, call 800.552.5512, visit ultradent.com or find us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

This news release contains forward-looking statements, including the expectations for and the terms of the agreement between Align and Ultradent the availability and capabilities of the combined Invisalign aligner and Opalescence offering, our beliefs regarding the market for the combined offering and the potential benefits to doctors, their offices and patients, and other similar comments or statements that are forward-looking in nature. Forward-looking statements contained in this news release relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement.

Factors that might cause such a difference include, but are not limited to:

• the impact of the COVID-19 pandemic on the health and safety of our employees, customers, patients, and our suppliers, as well as the physical and economic impacts of the various recommendations, orders, and protocols issued by local and national governmental agencies in light of continual evolution of the pandemic, including any periodic reimplementation of preventative measures in various global locations;
• difficulties predicting customer and consumer purchasing behavior and changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages, and consumer confidence, particularly in light of the pandemic and as pandemic-related restrictions are eased regionally and globally;
• unexpected or rapid changes in the growth or decline of our domestic and/or international markets;
• increasing competition from existing and new competitors;
• rapidly evolving and groundbreaking advances that fundamentally alter the dental industry or the way new and existing customers market and provide products and services to consumers;
• the ability to protect our intellectual property rights;
• continued compliance with regulatory requirements;
• declines in, or the slowing of the growth of, sales of our intraoral scanners domestically and/or internationally and the impact either would have on the adoption of Invisalign products;
• the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers;
• the possibility that the development and release of new products or enhancements to existing products do not proceed in accordance with the anticipated timeline or may themselves contain bugs or errors requiring remediation and that the market for the sale of these new or enhanced products may not develop as expected;
• a tougher consumer demand environment in China generally, especially for manufacturers and service providers whose headquarters or primarily operations are not based in China;
• the risks relating to our ability to sustain or increase profitability or revenue growth in future periods (or minimize declines) while controlling expenses;
• the impact of excess or constrained capacity at our manufacturing and treat operations facilities and pressure on our internal systems and personnel;
• the compromise of customer and/or patient data for any reason;
• the timing of case submissions from our doctors within a quarter as well as an increased manufacturing costs per case;
• foreign operational, political and other risks relating to our international manufacturing operations; and
• the loss of key personnel or work stoppages.

The foregoing and other risks are detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2021 and our latest Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which was filed with the SEC on August 4, 2021. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

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Align Technology Recognizes Teens for Their Community Efforts

Align Technology has recognized the community efforts of a hundred youths between the ages of 13 and 19 as part of its Invisalign ChangeMakers program. Launched in partnership with the National 4-H Council, each teen will receive a one-time $5,000 cash award to continue to bring positive change to their hometowns.

Applications from across the United States were accepted between January and March 2021. Thirty of the winners are active 4-H members. All of the winners will be recognized during a virtual awards ceremony on July 10 on YouTube hosted by executive producer and actor Marsai Martin, one of the stars of “Black-ish” and the upcoming “Paw Patrol: The Movie,” as well as an Invisalign patient.

The inaugural group of Invisalign ChangeMakers shared a wide variety of volunteer projects with judges, including delivery of handmade face masks and food to those in need during the height of the pandemic and making weighted blankets for children with autism. The winners also included:

• Sidney Keys III, 15, of Atlanta established “Books N Bros” to donate books to kids and help other boys get excited about reading books. He also stepped up additional volunteer efforts during the pandemic by collecting and donating more than a hundred boxes of food and masks to the needy.

• Benjamin Kagan, 15, of Chicago created Chicago Vaccine Angels, a service to help senior citizens schedule their COVID-19 vaccines and vet each location to ensure it was legitimate and accessible.

• Sruthi Sudarsan, 16, of San Ramon, California, recruited volunteers as president of her local 4-H club to create facemasks for healthcare and frontline workers from the onset of the pandemic. To date, more than 34,000 masks have been donated.

“At Align, we know the power of a smile and are inspired by the positive energy and commitment shared by all of the Invisalign ChangeMaker applicants who are leading the way to bring positive change and more smiles close to home,” said Raj Pudipeddi, chief innovation, product, and marketing officer and senior vice president at Align Technology.

“We congratulate the Invisalign ChangeMakers award recipients and look forward to celebrating these young leaders to recognize their community-focused accomplishments,” Pudipeddi said.

“We are thrilled to partner with the Invisalign brand and empower a hundred young leaders who are building a better and brighter future for us all,” said Ivan Heredia, senior vice president and chief marketing officer with the National 4-H Council.

“Through the ChangeMakers program, 4-H will continue to create opportunities for young people across the country as they discover their passions, build leadership skills, and develop confidence and compassion,” Heredia said.

“As an actress, bringing a smile to people’s faces is my greatest joy,” said Martin. “The power of a smile is limitless, as is the potential of these teens who are Invisalign ChangeMakers. They’re proof that even when you’re young, you can make a big impact.”

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