Clarity™ Aligners 358-455Recalls & reported problems
3m Unitek Corporation · 3M™ Clarity™ Aligner - Dual Arch · 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 00652221236463), received between Oct 20, 2020 and Oct 20, 2020 — 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
Device problems
- Insufficient Device Problem Information1
Patient problems
- Sensitivity of Teeth1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AN ORTHODONTIST REPORTED THAT A PATIENT HAD A ROOT CANAL PERFORMED ON TOOTH #10 AFTER DIFFICULTY EXPERIENCED WITH REMOVAL OF A 3M CLARITY ALIGNER AFTER OVERNIGHT WEAR. THE PATIENT CONTINUED TO WEAR THE ALIGNER AND TOOTH #10 TURNED GREY WITHIN THE FIRST WEEK OF WEAR. THE PATIENT VISITED AN ENDODONTIST AND THE TOOTH WAS OBSERVED FOR A FEW WEEKS, AFTER WHICH A ROOT CANAL WITH INTERNAL BLEACHING WAS PERFORMED. A COMPOSITE ON THE LINGUAL SIDE IS PLANNED.
Patient problems: Sensitivity of Teeth
MAUDE report 10708618 ↗
Other Aligner, sequential devices
- Byte Day Alignes HBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,719 reports
- Byte Night Aligners NBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,053 reports
- sequential aligner 100-0352Access Dental Lab, LLC · Aligner, Sequential322 reports
- 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™ 359-8353m 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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