GC Initial™ 010328
GC Initial™ 010328 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K153136 on 30 Jun 2016 and listed in FDA GUDID since 14 Nov 2016 (UDI-DI D0470103281), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD0470103281 | Date14 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153136 | Date30 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K153136
Across registries
- FDA 510(k) K153136 decided 30 Jun 2016 Active
- FDA GUDID UDI-DI D0470103281 listed 14 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K153136
- Listed FDA GUDID D0470103281
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GC Initial™
- Generic name
- Dental appliance fabrication material, ceramic
- Model / Ref / Catalog
- 010328
- Primary DI / UDI-DI
- D0470103281
- 510(k) Number
- FDA product code
- EIH
- GMDN term
- Dental appliance fabrication material, ceramic
- Device class
- Class II
- Regulation number
- 872.6660
- GUDID distribution status
- In Commercial Distribution
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