Identity
- Trade Name
- SleepRight FDA UDI
- Generic Name
- Custom-made mouthguard FDA UDI
- Device Name
- SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. FDA UDI
- Model / Reference
- ProRx FDA UDI
- Description
- SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00692121035216 FDA UDI
- FDA Product Code
- OBR FDA UDI
- GMDN Term
- Custom-made mouthguard FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made mouthguard
SleepRight by Splintek, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made mouthguard.
- ULTRAFLEX — Astron Dental · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- CORiTEC Splint Comfort — Pro3Dure Medical · U
- SML — Selane Products, Inc. · U
- Dentek — DenTek Oral Care, Inc. · U
- ASTRON LC — Astron Dental · Class II
- PRO3DURE THERMEO Blank — Pro3Dure Medical · U
- PRO3DURE THERMEO Powder — Pro3Dure Medical · U
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Splintek, Inc.
Sources (1)
- FDA UDI d7e55952-4520-41be-b43e-21354c82dfde 34 fields · synced May 30, 2026