Identity
- Trade Name
- GC CERAMIC PRIMER II FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- GC CERAMIC PRIMER II Unit Dose, 10 pieces FDA UDI
- Model / Reference
- 008620 FDA UDI
- Description
- GC CERAMIC PRIMER II Unit Dose, 10 pieces FDA UDI
Identifiers
- Catalog Number
- 008620 FDA UDI
- Primary DI / UDI-DI
- D0470086201 FDA UDI
- 510(k) Number
- K001823 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental repair kit, ceramic 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
Yes
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 repair kit, ceramic
Gc Ceramic Primer Ii by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental repair kit, ceramic.
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- EtchArrest — ULTRADENT PRODUCTS, INC. · Class II
- Etching Gel Kit — Cosmedent, Inc.
Cleared under the same submission
K001823 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
- Gc America Inc.
Sources (1)
- FDA UDI 04287939-0914-4337-be52-3e35cb510fe7 37 fields · synced May 30, 2026