FDA Registration
Active
🇰🇷 South Korea
Temporary Crown & Bridge Material
Reg #: 3006113314
·
FEI: 3006113314
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SPIDENT CO., LTD.
- Registration Number
- 3006113314
- FEI Number
- 3006113314
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 312, 151B-6L NAMDONGGONGDAN
- City
- INCHEON Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K214071
Owner / Operator
- Firm Name
- SPIDENT CO., LTD.
- Operator Number
- 9089446
- Address
- 312, 151B-6L NAMDONGGONGDAN, --
- City
- INCHEON
- State
- KR-NOTA
- Postal Code
- 405-821
- Country
- KR
US Agent
- Business Name
- Withus Group Inc
- Contact Name
- April Lee
- Address
- 106 Superior
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2022-05-03 |
Proprietary Names
Temporary Crown & Bridge Material
Hexa-Temp
vivid TemperFect
Provisa Plus Temporary Crown and Bridge
CromaTemp
EsTemp C&B
Establishment Types
Manufacture Medical Device