Retainer Brite® RB-92Recalls & reported problems
Dentsply Sirona Orthodontics Inc. · Retainer Brite® Cleaning Tablets - 96 ct · Class 1
- 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 D746RB921), received between Jun 3, 2025 and Jun 3, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE RETAINER BRITE® CLEANING TABLETS -96 CT KIT. THEY REPORTED THEIR SYMPTOMS OF SWOLLEN LIPS, TONGUE AND CHEEKS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 22131272 ↗
Other Cleanser, Denture, Over The Counter devices
- Cleaning Crystals, Packette 20127Align Technology, Inc. · Cleanser, Denture, Over The Counter3 reports
- EFFERDENT ORIGINAL 102CT TAB 6 10814832015876Medtech Products Inc. · Cleanser, Denture, Over The Counter1 report
- Retainer Brite® RB-36Dentsply Sirona Orthodontics Inc. · Cleanser, Denture, Over The Counter1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.