Identity
- Trade Name
- Ufi Gel hard C FDA UDI
- Generic Name
- Denture reliner, hard FDA UDI
- Device Name
- Hard direct denture relining. FDA UDI
- Model / Reference
- 2217 FDA UDI
- Description
- Hard direct denture relining. FDA UDI
Identifiers
- Catalog Number
- 2217 FDA UDI
- Primary DI / UDI-DI
- E22122171 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, hard 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, hard
Ufi Gel hard C by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, hard.
- Sinfony™ — 3M Deutschland GmbH · Class II
- Sinfony™ — 3M Deutschland GmbH · Class II
- Sinfony™ — 3M Deutschland GmbH · Class II
- Sinfony™ — 3M Deutschland GmbH · Class II
- KOOLINER™ — Gc America Inc. · Class II
- Sinfony™ — 3M Deutschland GmbH · Class II
- Sinfony™ — 3M Deutschland GmbH · Class II
- Sinfony™ — 3M Deutschland GmbH · 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
- VOCO GmbH
Sources (1)
- FDA UDI 6d06f939-362d-48c3-b347-b3b80fe85619 36 fields · synced Jun 8, 2026