The U.S. Food and Drug Administration is warning consumers about the risks of using unauthorized clear dental aligners sold directly to them without the supervision of a dentist or orthodontist.
In newly published information for patients, the FDA said clear aligners are prescription devices and that it reviews and authorizes the devices before they can be marketed and sold in the United States. The agency has not authorized clear aligners sold directly to consumers without a prescription and professional supervision, the notice emphasized.
Source: FDA warns public about unauthorized direct-to-consumer clear aligners / ADA News