APC™ Flash-Free Clarity™ ADVANCED 4006-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00652221217806), received between Dec 20, 2017 and Dec 20, 2017 — classified as 1 injury.

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.

• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2017, 3M WAS NOTIFIED THAT A (B)(6) OLD MALE PATIENT HAD A 3M UNITEK APC FLASH-FREE CLARITY ADVANCED UPPER LEFT BICUSPID BRACKET (UL5) DEBOND FROM TOOTH #13 WHILE EATING AN APPLE. THE DEBONDED BRACKET CONTAINED TOOTH ENAMEL. THE ORTHODONTIST REMOVED THE BRACKET THAT WAS STILL ATTACHED TO THE ARCHWIRE AND SENT THE PATIENT TO HIS DENTIST FOR RESTORATION OF THE ENAMEL. UPON 3M FOLLOW-UP WITH THE ORTHODONTIST, ENAMEL DAMAGE DOWN TO DENTIN WAS REPORTED. THE BRACKET WAS INITIALLY PLACED ON (B)(6) 2016. OTHER PRODUCTS USED WHEN THE BRACKET WAS PLACED INCLUDED A NON-3M ETCHANT AND 3M UNITEK TRANSBOND PLUS SELF-ETCHING PRIMER.

  Patient problems: Tooth Fracture

  MAUDE report 7134783 ↗