Identity
- Trade Name
- COPALITE FDA UDI
- Generic Name
- Dental restorative material varnish FDA UDI
- Device Name
- DENTAL VARNISH AND TUBULI SEAL FDA UDI
- Model / Reference
- 4001 FDA UDI
- Description
- DENTAL VARNISH AND TUBULI SEAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015110283 FDA UDI
- 510(k) Number
- K851030 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental restorative material varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 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
No
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: Dental restorative material varnish
Copalite by Temrex Corp. — 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
- GC Fuji VARNISH™ — Gc America Inc. · Class II
- Easy Glaze — VOCO GmbH · Class II
- ZenithDental — DMG America LLC · Class II
- Plaquit — Dreve Dentamid GmbH · Class II
- G-COAT PLUS™ — Gc America Inc. · Class II
- GlasIonomer F — SHOFU DENTAL CORP. · Class II
- ZenithDental — DMG America LLC · Class II
Cleared under the same submission
K851030 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
- Temrex Corp.
Sources (1)
- FDA UDI 65c2b692-8294-4685-8596-cd4bb84153e1 34 fields · synced May 30, 2026