Identity
- Trade Name
- UNIFAST™ FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B3, 2 bottles Liquid (15mL each), 2 rubber cups, Spatula and powder measure FDA UDI
- Model / Reference
- 338013 FDA UDI
- Description
- UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B3, 2 bottles Liquid (15mL each), 2 rubber cups, Spatula and powder measure FDA UDI
Identifiers
- Catalog Number
- 338013 FDA UDI
- Primary DI / UDI-DI
- D6583380131 FDA UDI
- 510(k) Number
- K890829 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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: Temporary dental crown/bridge resin
Unifast™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Temporary dental crown/bridge resin.
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- PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- tempofit premium BL — DETAX GmbH · Class II
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- YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II
Cleared under the same submission
K890829 also covers:
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
- UNIFAST™ — Gc America Inc.
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
- Gc America Inc.
Sources (1)
- FDA UDI 2ad907e6-6b25-424e-842d-c213513abf7d 36 fields · synced May 30, 2026