APC™ Flash-Free Clarity™ ADVANCED 4006-250Recalls & reported problems
3m Unitek Corporation · Clarity(TM) ADVANCED Ceramic Bracket APC(TM) Flash-Free MBT(TM) L1,2 -6T/0A .018 5/Pk · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00652221166005), received between Oct 20, 2016 and Oct 20, 2016 — 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Tooth Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS AT ORTHODONTIST TO HAVE BRACES REMOVED AT END OF TREATMENT. UPON DEBONDING THE LOWER RIGHT CENTRAL ANTERIOR BRACKET, THE TOOTH BROKE HORIZONTALLY AT THE LOWER GINGIVAL 3RD. THE PATIENT SAW AN ENDODONTIST, WHO PERFORMED A ROOT CANAL AND PLACED A TEMPORARY CROWN, THEN A PERMANENT CROWN.
Patient problems: Tooth Fracture
MAUDE report 6046138 ↗
Other Bracket, ceramic, orthodontic devices
- APC™ II Clarity™ ADVANCED 3006-3593m Unitek Corporation · Bracket, ceramic, orthodontic2 reports
- Reflections REF-571Ortho Technology, Inc. · Bracket, ceramic, orthodontic1 report
- APC™ Flash-Free Clarity™ ADVANCED 4006-3133m Unitek Corporation · Bracket, ceramic, orthodontic1 report
- Carriere® SLX 3D™ 776-LR4-HK-RPOrtho Organizers, Inc. · Bracket, ceramic, orthodontic1 report
- CLEARVIZ MINI 300XXOrtho Solutions, LC · Bracket, Ceramic, Orthodontic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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