FDA Registration
Active
🇺🇸 United States
GC Initial Zirconia Disk HT
Reg #: 1410097
·
FEI: 1410097
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GC AMERICA INC.
- Registration Number
- 1410097
- FEI Number
- 1410097
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3737 W 127th St
- City
- ALSIP
- State
- IL
- ZIP
- 60803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082740
Owner / Operator
- Firm Name
- GC America Inc.
- Operator Number
- 8030268
- Address
- 3737 W. 127th Street
- City
- Alsip
- State
- IL
- Postal Code
- 60803
- Country
- US
- Correspondent
- Futoshi Fusejima
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2009-01-12 |
Proprietary Names
GC Initial Zirconia Disk HT
GC Initial Zirconia Disk ST
GC Aadva Zr Disk
GC Initial ZR Disk ML Elite
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device