SmileSet Retainers 140-0101Recalls & reported problems
Ortho Dental Lab LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00860012825592), received between Sep 2, 2026 and Sep 2, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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
- Adverse Event Without Identified Device or Use Problem9
- Insufficient Device Problem Information8
Patient problems
- Tooth Fracture9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Deformity/ Disfigurement3
- Tooth Loss1
- Unspecified Infection1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Insufficient Device Problem Information
Patient problems: Tooth Fracture
MAUDE report 50575416 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Tooth Fracture
MAUDE report 50574544 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Deformity/ Disfigurement
MAUDE report 50574543 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50574539 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Tooth Fracture
MAUDE report 50574538 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Tooth Fracture
MAUDE report 50574536 ↗InjurySep 2, 2026Insufficient Device Problem Information
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50574533 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Tooth Fracture
MAUDE report 50574530 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Tooth Loss
MAUDE report 50574529 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Tooth Fracture
MAUDE report 50574523 ↗InjurySep 2, 2026Insufficient Device Problem Information
Two front teeth loosening.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50555997 ↗InjurySep 2, 2026Insufficient Device Problem Information
Two implant-supported units reported cracked.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50555994 ↗InjurySep 2, 2026Insufficient Device Problem Information
InjurySep 2, 2026Insufficient Device Problem Information
Crown became dislodged when removing bottom retainer.
Patient problems: Deformity/ Disfigurement
MAUDE report 50555989 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
InjurySep 2, 2026Insufficient Device Problem Information
Molar pain when biting; molar later broke while eating; crown subsequently placed on the affected tooth (cross-referenced case (b)(4)).
Patient problems: Tooth Fracture
MAUDE report 50555987 ↗InjurySep 2, 2026Insufficient Device Problem Information
The retainer pulled off a crown on removal.
Patient problems: Deformity/ Disfigurement
MAUDE report 50555985 ↗
Other Positioner, Tooth, Preformed devices
- Byte Retainer BYTERetainerTrayStraight Smile LLC · Positioner, Tooth, Preformed1,954 reports
- RETAINER KIT 100-0354Access Dental Lab, LLC · Positioner, Tooth, Preformed42 reports
- SureSmile® 1000Orametrix, Inc. · Positioner, Tooth, Preformed39 reports
- ClearCorrect System RetainerClearcorrect Operating, LLC · Positioner, Tooth, Preformed3 reports
- IPS 60-500-01-09KLS-Martin L.P. · POSITIONER, TOOTH, PREFORMED2 reports
- Herbst Bite Jumper 3000-0010Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
- Distal Jet 3000-0090Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
- Essix A+ 10045Dentsply Sirona Orthodontics Inc. · POSITIONER, TOOTH, PREFORMED1 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 13, 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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