Reveal® Aligners 570-1422Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190707089788), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT ADVISED THE DOCTOR'S OFFICE THAT HER TEETH HAVE CHIPPED DURING TREATMENT WITH THE REVEAL CLEAR ALIGNERS. THE COMPLAINT AND SUPPORTING DOCUMENTATION STATE THAT THE (B)(6)-YEAR OLD PATIENT REPORTED TO THE DOCTOR'S OFFICE THAT HER LOWER TEETH HAD CHIPPED AFTER THE FIRST ALIGNER TRAY WAS SWITCHED. SHE REPORTED THAT UPPER TOOTH #8 CHIPPED ON INSIDE CORNER AND LOWER TOOTH # 25 CHIPPED ON TOP OF OCCLUSAL MARGIN DUE TO THE TOOTH MOVEMENT AFTER WEARING THE ALIGNERS FOR ONLY A FEW WEEKS. THE RETURNED QUESTIONNAIRE DID NOT INDICATE WHETHER THE PATIENT WORE THE ALIGNERS AT THE TIME. IN A LETTER SUBMITTED BY THE PATIENT, SHE DESCRIBED THAT - AFTER TWO WEEKS OF WEARING THE ALIGNERS - HER UPPER TEETH WOULD HIT HER LOWER TEETH WHEN SHE REMOVED THE ALIGNERS TO EAT. SHE WENT ON TO SAY THAT ONE WEEK LATER TWO OF HER TEETH HAD CHIPPED. WHILE THE PATIENT DID NOT SPECIFICALLY MENTION THIS, IT CAN BE REASONABLY ASSUMED THAT HER TEETH CHIPPED AFTER SHE REMOVED THE ALIGNERS AND WHILE SHE WAS EATING.

  Patient problems: Tooth Fracture

  MAUDE report 12833494 ↗