Identity
- Trade Name
- Plaquit FDA UDI
- Generic Name
- Dental restorative material varnish FDA UDI
- Device Name
- No. FDA UDI
- Model / Reference
- D38123US FDA UDI
- Description
- No. FDA UDI
Identifiers
- Catalog Number
- D38123US FDA UDI
- Primary DI / UDI-DI
- E239D38123US1 FDA UDI
- 510(k) Number
- K162408 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Dental restorative material varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 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: Dental restorative material varnish
Plaquit by Dreve Dentamid GmbH — 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
- COPALITE — Temrex Corp. · Class II
- G-COAT PLUS™ — Gc America Inc. · Class II
- GlasIonomer F — SHOFU DENTAL CORP. · Class II
- COPALITE — Temrex Corp. · Class II
Cleared under the same submission
K162408 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 |
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Manufacturer
- Manufacturer
- Dreve Dentamid GmbH
Sources (1)
- FDA UDI 88379786-0bc9-4e9f-bb68-9b14a9c9a24d 37 fields · synced Jun 6, 2026