Clarity Aligners

Dental bodies caution against straightening teeth without an in-person exam

The American Dental Association maintains a standing policy discouraging direct-to-consumer teeth straightening, reaffirmed in December 2023 on patient-safety grounds. The American Association of Orthodontists holds that treatment should be under the in-person supervision of a licensed orthodontist, warns that moving teeth without an exam and X-rays can miss gum disease or cavities and cause irreversible, expensive harm (bone and tooth loss, receding gums, changed bites), and urges patients to report problems to the FDA. See a dentist before starting, and stop and seek care if you notice pain, looseness, or bleeding.

American Dental Association; American Association of Orthodontists · as of Dec 1, 2023

Reported harms in the FDA device adverse-event database

Thousands of adverse-event reports have been filed with the FDA under the sequential clear-aligner product code (NXC), the large majority coded as injuries, spanning both in-office and at-home brands. A peer-reviewed analysis of the NXC reports filed from 2010 to 2020 (651 reports, 104 of them involving direct-to-consumer aligners) found the direct-to-consumer reports dominated by bite problems (41.3%), orofacial pain (29.8%) and periodontal harm (26.6%) such as loose teeth, gum recession and bone loss, with tooth sensitivity, jaw (TMJ) problems, fractured teeth and tooth loss also reported; the authors note that some of these harms are irreversible. These are unverified spontaneous reports, not incidence rates, and do not establish that any device caused the event, but they underline why an in-person check and professional oversight matter.

Belgal et al., Dentistry Journal 2023 (analysis of FDA MAUDE reports, product code NXC) · as of Sep 30, 2026

Clarity Aligners: open Class II recall of Clarity Precision Grip Attachments

On November 22, 2024, 3M began a voluntary Class II recall (Z-0743-2025) of Clarity Precision Grip Attachments, which are used with Clarity Aligners, because a software nonconformance meant that attachments for the lower arch of specific dual-arch orders may not mate with the tooth as intended in the digital treatment design. The recall covers 171 orders distributed in the US, Canada, Australia and New Zealand, and practices were told not to use, and to dispose of, product from the affected case IDs. The FDA lists the recall as open. A Clarity patient with concerns about how their attachments fit should ask their orthodontist.

U.S. Food & Drug Administration, medical device recall database (recall Z-0743-2025) · as of Nov 22, 2024