Identity
- Trade Name
- GC Initial™ FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- GC Initial™ MC Opaqus Dentin ODA1, 20g FDA UDI
- Model / Reference
- 870031 FDA UDI
- Description
- GC Initial™ MC Opaqus Dentin ODA1, 20g FDA UDI
Identifiers
- Catalog Number
- 870031 FDA UDI
- Primary DI / UDI-DI
- J0228700311 FDA UDI
- 510(k) Number
- K040567 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 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
- Weight — 20 Gram FDA UDI
Category: Dental appliance fabrication material, ceramic
GC Initial™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
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Cleared under the same submission
K040567 also covers:
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
- GC Initial™ — Gc America Inc.
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 22a065e3-d670-4760-b190-cc2db8c9f93a 38 fields · synced Jun 8, 2026