The U.S. Food and Drug Administration (FDA) has published a new consumer webpage about clear aligners that aims to explain their benefits, risks, and the importance of continued supervision by a licensed dentist or orthodontist.
The FDA emphasizes that clear aligners are medical devices that are only available via prescription and require supervision from a licensed clinician. Furthermore, it notes that the FDA has not authorized for clear aligners to be sold directly to consumers or without in-person, proper oversight by a dental professional, according to the webpage.
Additionally, the agency warns that direct-to-consumer aligners can cause severe problems, including tooth pain and loss. Also, treatment with remote-only patient monitoring may lead to complications, according to the webpage.
The FDA also explains how to report adverse events associated with clear aligners.
