The U.S. Food and Drug Administration recently released new webpages emphasizing the importance of professional supervision and in-person evaluation for prescription clear aligner treatment, resources that AGD supports. The new consumer webpage is dedicated to clear dental aligners, along with an updated resource on traditional braces and clear aligner options. The new materials underscore key patient-safety principles that AGD has long advocated.

The FDA’s Center for Devices and Radiological Health (CDRH), Office of Health Technology 1, which oversees regulation of dental devices including braces and clear aligners, published the resources following outreach from AGD regarding concerns about the marketing of clear dental aligners. AGD appreciates the agency’s responsiveness and its ongoing collaboration to advance dental health for the American public.

The new Clear Dental Aligners webpage helps patients understand the benefits, risks and appropriate use of these prescription medical devices. It specifically explains:

FDA also updated its consumer page on braces. The pages are available at:

Clear dental aligners are Class II prescription medical devices regulated by the FDA. AGD continues to advocate that treatment involving these devices should begin with a thorough clinical examination by a licensed dentist or orthodontist and include appropriate ongoing care to ensure safe and effective outcomes.