Identity
- Trade Name
- initial EUDAMEDGC Initial™ FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- initial EUDAMEDGC Initial™ AL Shoulder Transpa ST-33, 20g FDA UDI
- Model / Reference
- 874078 EUDAMEDFDA UDI
- Description
- GC Initial™ AL Shoulder Transpa ST-33, 20g FDA UDI
Identifiers
- Catalog Number
- 874078 FDA UDI
- Primary DI / UDI-DI
- 15400556704964 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J022MD0072KB EUDAMED
- Direct Marketing DI
- 15400556715793 EUDAMED
- 510(k) Number
- K040567 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
GC Initial™ by Gc America Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI c452ebf9-8d4a-453c-9ded-677a1c4f465b 37 fields · synced Jul 8, 2026
- EUDAMED ead9819d-83ea-432d-8f9e-af5a07a83de6 61 fields · synced Jul 8, 2026