Identity
- Trade Name
- Tuf-Link II FDA UDI
- Generic Name
- Denture reliner, elastic, long-term FDA UDI
- Device Name
- TUF-LINK 50 ml syringe Silicone Material incl. 10 mixing tips for TK-G Dispenser Gun. FDA UDI
- Model / Reference
- TK-502 FDA UDI
- Description
- TUF-LINK 50 ml syringe Silicone Material incl. 10 mixing tips for TK-G Dispenser Gun. FDA UDI
Identifiers
- Catalog Number
- TK-502 FDA UDI
- Primary DI / UDI-DI
- 07350081494827 FDA UDI
- 510(k) Number
- K042931 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
Yes
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
Tuf-Link II by Dentatus AB — 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
- Sofreliner Tough — TOKUYAMA DENTAL CORPORATION · Class II
- Sofreliner Tough — TOKUYAMA DENTAL CORPORATION · Class II
- Ultraprint-Dental Denture UV 1000 g — DETAX GmbH · Class II
- Sofreliner Tough — TOKUYAMA DENTAL CORPORATION · Class II
- VITA VIONIC® BASE RESIN IMPACT pink 1000g — DETAX GmbH · Class II
Cleared under the same submission
K042931 also covers:
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
- Dentatus AB
Sources (1)
- FDA UDI 03b16492-5305-44d3-a9c1-1abf62acb851 37 fields · synced Jun 8, 2026