Identity
- Trade Name
- Retainer Brite® FDA UDI
- Generic Name
- Orthodontic appliance cleanser FDA UDI
- Device Name
- Retainer Brite® Cleaning Tablets - 96 ct FDA UDI
- Model / Reference
- RB-92 FDA UDI
- Description
- Retainer Brite® Cleaning Tablets - 96 ct FDA UDI
Identifiers
- Catalog Number
- RB-92 FDA UDI
- Primary DI / UDI-DI
- D746RB921 FDA UDI
- FDA Product Code
- EFT FDA UDI
- GMDN Term
- Orthodontic appliance cleanser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic appliance cleanser
Retainer Brite® by Dentsply Sirona Orthodontics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance cleanser.
- Cleaning Crystals, Packette — Align Technology, Inc. · Class I
- SmileSet Universal Cleaning Tablets - Sample 6pc — ORTHO DENTAL LAB, LLC · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- Retainer Brite® — Dentsply Sirona Orthodontics Inc. · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- Retainer Brite® — Dentsply Sirona Orthodontics Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Sirona Orthodontics Inc.
Sources (1)
- FDA UDI c3edcfe9-6538-4599-bf69-72359a47b79c 35 fields · synced Jun 9, 2026