NYSDA Publications

FDA Provides Information for Consumers Considering Clear Dental Aligners

Sep 9, 2026

FDA Provides Information for Consumers Considering Clear Dental Aligners

The U.S. Food and Drug Administration (FDA) has published a new consumer webpage about clear dental aligners to help patients understand the benefits, risks, and appropriate use of these prescription medical devices.  The webpage explains:

  • The importance of ongoing supervision by a licensed practitioner, such as a dentist or orthodontist,
  • Why an in-person evaluation before treatment is beneficial,
  • The steps generally involved when getting treatment, and
  • How to report adverse events associated with clear aligners.

Questions?

If you have questions about this communication, contact CDRH’s Division of Industry and Consumer Education (DICE).