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 responded to the European Commission’s June 30 press release announcing an investigation involving the Company based on a complaint made by an Align competitor.
Align Technology is committed to conducting business with integrity and in full compliance with global competition laws. We believe fair, lawful competition drives innovation, expands choice, and delivers better outcomes for doctors and patients. Our success in the teeth-straightening market is built on the strength of our products and services — quality, innovation, and customer experience — not on unfair practices, and we strongly dispute any suggestion to the contrary.
Align’s iTero intraoral scanning platform is designed to support an open and diverse digital dental ecosystem, and supports a wide range of clinical workflows, including implants, restorative dentistry, digital orthodontics, and clear aligner treatment. iTero generated scans can be freely exported to order aligners other than Invisalign aligners. Align maintains a scan acceptance policy designed to ensure clinical quality, patient safety, and system reliability, including validation requirements for digital file submissions and the operational resources needed to support consistent processing across workflows.
The iTero intraoral scanning platform is used globally by dental professionals across diverse treatment modalities, with millions of scans performed annually, reflecting its role in enabling a broad and competitive marketplace for digital dentistry solutions. Since 2018, the iTero scanner has been used by healthcare professionals to perform over 24 million restorative, wellness, and orthodontic scans.
The Commission’s step is purely procedural and allows it to gather information. It does not reflect a conclusion on the merits of the case, nor does it constitute an accusation or a finding of wrongdoing. The opening of an investigation does not prejudge its outcome.
Align is confident that any review of Align’s scanner and scan acceptance policies will reflect the robust and dynamic nature of the teeth-straightening market and believes its practices comply with applicable competition laws. We will cooperate fully and engage constructively with the Commission through the appropriate channels.
For nearly 30 years, Align Technology has helped transform a market long dominated by wires and brackets, offering meaningful choices to customers across Europe and around the world. By introducing innovative digital dentistry solutions that expand treatment possibilities for doctors and their patients, Align has helped doctors transform smiles and change lives for millions of patients, a testament to the value of innovation and better patient experience. What began as an innovation has grown into a widely accepted treatment category, one that now extends beyond Invisalign aligners and iTero scanners across a diverse and competitive ecosystem.
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 299.5 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 29 years, Align has helped doctors treat approximately 22.8 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, Align Digital Platform and iTero Lumina are trademarks of Align Technology, Inc.
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Align Technology
Madelyn Valente
(909) 833-5839
mvalente@aligntech.com
Zeno Group
Sarah Karlson
(828) 551-4201
sarah.karlson@zenogroup.com