FDA Registration
Active
🇯🇵 Japan
GC ASAHI CORPORATION
Reg #: 3004146043
·
FEI: 3004146043
·
Expires 2026
Products
4
Proprietary Names
15
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GC ASAHI CORPORATION
- Registration Number
- 3004146043
- FEI Number
- 3004146043
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1-3-3 KACHIGAWA-CHO, KASUGAI-SHI
- City
- AICHI
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K951555
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 |
|---|---|---|---|---|---|
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2005-04-28 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2010-02-25 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2014-03-10 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2018-03-22 |
Proprietary Names
POLISHING STRIPS
Ultimate Finishing & Polishing Kit
GC Metal Strips
EPITEX
EPITEX FINISHING
Fuji Varnish
Fuji IX
Fuji IX ART
GC Gold Label 9 HS Post. Rest.
Nanocoat Color
Optiglaza Color
Optiglaze
G-aenial Bulk Injectable
G-aenial Universal Injectable NMF004A
CAVITRON
Establishment Types
Manufacture Medical Device