FDA Registration
Active
🇯🇵 Japan
G-Cem
Reg #: 9612300
·
FEI: 3002808289
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GC CORP.
- Registration Number
- 9612300
- FEI Number
- 3002808289
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 76-1 HASUNUMA-CHO
- City
- ITABASHI-KU Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K061535
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
US Agent
- Business Name
- GC America Inc.
- Contact Name
- Futoshi Fusejima
- Address
- 3737 W 127th St
- City
- Alsip
- State
- IL
- ZIP
- 60803
- Country
- US
- [email protected]
- Phone
- 708 9263050
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Dental | EMA | Class 2 | Dental | No | 2008-01-31 |
Proprietary Names
G-Cem
G-CEM CAPSULE
Establishment Types
Manufacture Medical Device