sureclear aligner 1000Recalls & reported problems
Orametrix, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00856379007009), received between Aug 15, 2023 and Oct 16, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility3
Patient problems
- Hypersensitivity/Allergic reaction2
- Nerve Damage1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT COMPLAINT THROUGH SOCIAL MEDIA THEY EXPERIENCED NUMB CHIN SYNDROME FROM THE USE OF THE TEMPLATE ALIGNER ARCH - SURESMILE. THEY WERE SEEN BY AN ORAL SPECIALIST WHO SAID THAT THE NUMB CHIN IS BEING CAUSED BY COMPRESSION OF THEIR LOWER INCISOR AND GUM FROM THE ALIGNERS. THEY WERE ADVISED IT HOPEFULLY CAN BE REVERSED BUT COULD BE A LONG ROAD TO RECOVERY, POSSIBLY REQUIRING MEDICATION TO HELP THE NERVE RECOVER. THEY HAVE BEEN ADVISED TO STOP WEARING THE ALIGNERS IMMEDIATELY.
Patient problems: Nerve Damage; Pain
MAUDE report 23308722 ↗InjuryOct 4, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT PATIENT EXPERIENCED ALLERGIC REACTION TO ORTHODONTIC ALIGNERS. PATIENT REPORTEDLY EXPERIENCED SWOLLEN FACE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17868623 ↗InjuryAug 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION WHILE WEARING TEMPLATE ALIGNER ARCH. THE PATIENT RECEIVED CORTISONE TO TREAT THE REACTION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17549222 ↗
Other Aligner, Sequential devices
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- 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™ 359-8343m 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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