SmileSet Nighttime Aligners 122-0101Recalls & reported problems
Ortho Dental Lab LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860014476105), received between Jul 16, 2026 and Jul 16, 2026 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Atrophy1
- Tooth Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2026Insufficient Device Problem Information
DURING A ROUTINE CHECKUP, PATIENT'S DENTIST PERFORMED A PHYSICAL EXAM AND X-RAYS AND ALLEGED SIGNIFICANT CHANGES: JAW POPPING/CLICKING, SMALLER TOOTH ROOTS, AND SIGNIFICANT BONE LOSS. THE DENTIST ATTRIBUTED THESE FINDINGS TO THE ALIGNERS, NOTING THEY WERE THE ONLY CHANGE IN THE PATIENT'S ORAL CARE ROUTINE, AND ADVISED THE PATIENT TO DISCONTINUE USE.
Patient problems: Atrophy
MAUDE report 25849973 ↗InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem
AT THE START OF THE THIRD ALIGNER THE PATIENT NOTICED SHE WAS UNABLE TO FLOSS BETWEEN HER BOTTOM LEFT FIRST MOLAR AND THE SECOND MOLAR. PATIENT THOUGHT IT WOULD STRAIGHTEN OUT AND THE PROBLEM WOULD RESOLVE BUT ABOUT A WEEK INTO THE THIRD ALIGNER HER FILLING CAME LOOSE AND HER TOOTH CRACKED.
Patient problems: Tooth Fracture
MAUDE report 25849913 ↗
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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™ 359-8353m 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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