Identity
- Trade Name
- ZenithDental FDA UDI
- Generic Name
- Dental restorative material varnish FDA UDI
- Device Name
- ZenithDental Core Material 1-14g base, 1-14g Catalyst and mising pads/spatulas FDA UDI
- Model / Reference
- 61055 FDA UDI
- Description
- ZenithDental Core Material 1-14g base, 1-14g Catalyst and mising pads/spatulas FDA UDI
Identifiers
- Catalog Number
- 003-61055 FDA UDI
- Primary DI / UDI-DI
- D033610551 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
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
Dimensions & Sizes
- Size
- Weight — 28 Gram FDA UDI
Category: Dental restorative material varnish
ZenithDental by DMG America LLC — 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
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- COPALITE — Temrex Corp. · Class II
- Plaquit — Dreve Dentamid GmbH · Class II
- G-COAT PLUS™ — Gc America Inc. · Class II
- GlasIonomer F — SHOFU DENTAL CORP. · Class II
- COPALITE — Temrex Corp. · 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 |
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Manufacturer
- Manufacturer
- DMG America LLC
Sources (1)
- FDA UDI 440d6863-e199-4699-a97a-06341bf2addc 37 fields · synced May 30, 2026