GC Initial™ 010322
GC Initial™ 010322 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 D0470103221), 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 | NumberD0470103221 | 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 D0470103221 listed 14 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K153136
- Listed FDA GUDID D0470103221
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- Withdrawn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
- 010322
- Primary DI / UDI-DI
- D0470103221
- 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
Similar devices in this category
Other devices filed under Dental appliance fabrication material, ceramic.
- Celtra Ceram 650215 by Dentsply International
- TMS Complete-Kit, Minuta Pink, Gold-Plated Stainless Steel, 20 pcs T111 by Coltene/Whaledent Inc.
- Amber® Mill Q Amber Mill Q MT C14/B2 TB5.4L by Hass Corporation
- Amber® Mill Q Amber Mill Q LT C16/D2 TB4.1L by Hass Corporation
- Ceramco® 3 Paste Opaque Shade Series C3-101 303010 by Dentsply International
- Zirlux 9012318 by HENRY SCHEIN, INC.
- Implant Locator iD3 by Guilin Yahope Medical Technology Co., Ltd.
- 20 ParaPost Titanium Temporary Posts (.050" / 1.25mm) P465 by Coltene/Whaledent Inc.
- EMS Threaded Tip CPR-8E 932-008 by Young Innovations, Inc.