Identity
- Trade Name
- Sofreliner Tough FDA UDI
- Generic Name
- Denture reliner, elastic, long-term FDA UDI
- Device Name
- Primer FDA UDI
- Model / Reference
- 23441 FDA UDI
- Description
- Primer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548190234417 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, elastic, long-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture reliner, elastic, long-term
Sofreliner Tough by Tokuyama Dental Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, elastic, long-term.
- Freeprint denture 385 500g — DETAX GmbH & Co. KG · Class II
- mollosil plus Polish 2 x 7 ml — DETAX GmbH · Class II
- PROVISA — BENCO DENTAL SUPPLY CO. · Class II
- Ultraprint-Dental Denture UV 1000 g — DETAX GmbH · Class II
- VITA VIONIC® BASE RESIN IMPACT pink 1000g — DETAX GmbH · Class II
- Molloplast B 170 g — DETAX GmbH · Class II
- VITA VIONIC® BASE RESIN IMPACT pink-translucent 1000g — DETAX GmbH · Class II
- PROVISA — BENCO DENTAL SUPPLY CO. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tokuyama Dental Corporation
Sources (1)
- FDA UDI 8fa655c4-0fcc-4b2b-a85f-c0b6914f1094 35 fields · synced May 30, 2026