3M™ Clarity™ 359-455Recalls & reported problems
3m Unitek Corporation · 3M™ Clarity™ Aligners Dual Arch, 359-455 · Class 2
All models of 3M Clarity (9)
Data updated Oct 16, 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 00652221290878), received between Jun 25, 2021 and Jun 25, 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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Cellulitis1
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
A THREE-DAY HOSPITALIZATION FOR SUBMENTAL CELLULITIS OF THE NECK WAS REPORTED THAT RESULTED DURING ORTHODONTIC TREATMENT WITH 3M CLARITY ALIGNERS. PRIOR TO THE HOSPITALIZATION, THE ALIGNERS WERE TRIMMED DUE TO ALLEGED CUTTING OF THE TONGUE AND ROOF OF THE MOUTH. TREATMENT INCLUDED ADMINISTRATION OF AN INTRAVENOUS ANTIBIOTIC (UNSPECIFIED) AND ORAL CLINDAMYCIN UPON DISCHARGE. DISCHARGE INSTRUCTED TO COMPLETE THE COURSE OF ANTIBIOTICS AS PRESCRIBED, TO APPLY WARM COMPRESSES TO THE AFFECTED AREA. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CELLULITIS WAS CAUSED BY AN INSECT BITE. THE PATIENT IS CONTINUING ORTHODONTIC TREATMENT WITH 3M CLARITY ALIGNERS.
Patient problems: Cellulitis; Laceration(s)
MAUDE report 12067947 ↗
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- Invisalign System - Comprehensive 9000Align Technology, Inc. · Aligner, Sequential239 reports
- SureSmile® 1000Orametrix, Inc. · Aligner, Sequential134 reports
- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8343m Unitek Corporation · Aligner, sequential1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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