FDA Says It Has Not Authorized Clear Aligners Sold Without Dentist Supervision

Edited by Orthotown staff

The Food and Drug Administration published guidance for the public Sept. 9 stating that clear dental aligners are prescription devices and that the agency has not authorized aligners sold directly to consumers without a prescription and supervision by a dentist or orthodontist.

The agency said clear aligners are safe to use only under the supervision of a licensed practitioner, and that using them without proper professional supervision may increase the risk of complications. It recommended an in-person examination before treatment to reduce the risks of uneven bite, unintended tooth movement, pain, and tooth loss, and periodic in-person visits afterward to confirm teeth are moving safely and as planned.

The FDA said it has received reports involving non-authorized direct-to-consumer aligners in which patients experienced new or worsening dental pain, jaw pain, bite problems, worsening tooth misalignment, and new gaps between teeth.

On remote care, the agency said some treatment plans may include remote monitoring and virtual dental visits, and that while virtual visits can be a useful part of dental care, periodic in-person visits help reduce the risks it identified.

The agency also drew a distinction between two claims that appear in marketing. A manufacturer describing itself as FDA registered has listed its facility and products with the agency, the FDA said, while FDA authorized means the agency actively reviewed a specific product and cleared or approved it. Patients can check whether a specific aligner has been authorized by searching the agency’s 510(k) database under product code NXC.

The agency noted that clear aligners are commonly used for mild to moderate orthodontic problems including crowding, spacing, and bite problems, and that more complex conditions may require traditional braces or other treatments.

Serious adverse events involving aligners should be reported to the manufacturer and to the FDA through its MedWatch program, the agency said.

Sources:
U.S. Food and Drug Administration, “Clear Dental Aligners,” content current as of Sept. 9, 2026: fda.gov/medical-devices/dental-devices/clear-dental-aligners
U.S. Food and Drug Administration, CDRH New — News and Updates: fda.gov/medical-devices/cdrh-new-news-and-updates