APC™ II Clarity™ ADVANCED 3006-359Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00652221162717), received between Jun 22, 2018 and Jun 22, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, 3M WAS NOTIFIED THAT A FEMALE PATIENT, APPROXIMATELY (B)(6), HAD A LARGE BUCCAL FILLING BREAK OFF FROM A PREVIOUSLY RESTORED UPPER PRE-MOLAR TOOTH UPON DEBONDING OF A 3M APC II CLARITY ADVANCED CERAMIC BRACKET. THE BREAK WAS REPORTED TO BE DOWN TO DENTIN. THE BRACKET HAD BEEN IN PLACE FOR APPROXIMATELY 18 MONTHS. THE ORTHODONTIST REPORTED THAT THE LARGE FILLING/RESTORATION ON THE TOOTH DID NOT LOOK NORMAL. OTHER PRODUCTS USED WHEN THE BRACKET WAS INITIALLY BONDED INCLUDED A NON-3M BRAND ETCHANT. IN ADDITION, ALTHOUGH THE BRAND OF THE PRIMER OR CATALOG NUMBER WAS NOT DISCLOSED BY THE REPORTING FACILITY, BASED UPON A DESCRIPTION OF THE PRODUCT AND SALES HISTORY, IT IS SUSPECTED THAT 3M TRANSBOND PLUS SELF ETCHING PRIMER WAS ALSO POTENTIALLY USED.

  Patient problems: Tooth Fracture

  MAUDE report 7631096 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, 3M WAS NOTIFIED THAT A FEMALE PATIENT, APPROXIMATELY (B)(6), HAD A LARGE BUCCAL FILLING BREAK OFF FROM A PREVIOUSLY RESTORED UPPER PRE-MOLAR TOOTH UPON DEBONDING OF A 3M APC II CLARITY ADVANCED CERAMIC BRACKET. THE BREAK WAS REPORTED TO BE DOWN TO DENTIN. THE BRACKET HAD BEEN IN PLACE FOR APPROXIMATELY 18 MONTHS. THE ORTHODONTIST REPORTED THAT THE LARGE FILLING/RESTORATION ON THE TOOTH DID NOT LOOK NORMAL. OTHER PRODUCTS USED WHEN THE BRACKET WAS INITIALLY BONDED INCLUDED A NON-3M BRAND ETCHANT. IN ADDITION, ALTHOUGH THE BRAND OF THE PRIMER OR CATALOG NUMBER WAS NOT DISCLOSED BY THE REPORTING FACILITY, BASED UPON A DESCRIPTION OF THE PRODUCT AND SALES HISTORY, IT IS SUSPECTED THAT 3M TRANSBOND PLUS SELF ETCHING PRIMER WAS ALSO POTENTIALLY USED.

  Patient problems: Tooth Fracture

  MAUDE report 7631089 ↗