Identity
- Trade Name
- GC Fuji COAT™ FDA UDI
- Generic Name
- Dental restorative material varnish FDA UDI
- Device Name
- GC Fuji COAT™ LC 5.2 mL liquid FDA UDI
- Model / Reference
- 000176 FDA UDI
- Description
- GC Fuji COAT™ LC 5.2 mL liquid FDA UDI
Identifiers
- Catalog Number
- 000176 FDA UDI
- Primary DI / UDI-DI
- 14548161282697 FDA UDI
- 510(k) Number
- K935961 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental restorative material varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
Dimensions & Sizes
- Size
- Total Volume — 5.2 Milliliter FDA UDI
Category: Dental restorative material varnish
GC Fuji COAT™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental restorative material varnish.
- LuxaGlaze® — DMG Chemisch-Pharmazeutische Fabrik GmbH · Class II
- Easy Glaze — VOCO GmbH · Class II
- ZenithDental — DMG America LLC · Class II
- COPALITE — Temrex Corp. · Class II
- Plaquit — Dreve Dentamid GmbH · Class II
- GlasIonomer F — SHOFU DENTAL CORP. · Class II
- COPALITE — Temrex Corp. · Class II
- ZenithDental — DMG America LLC · Class II
Cleared under the same submission
K935961 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
- Gc America Inc.
Sources (1)
- FDA UDI a1ddb912-a297-454b-a492-03bc7fbd0761 38 fields · synced May 30, 2026