FDA Registration
Active
🇰🇷 South Korea
BR Pick-Up Impression Coping
Reg #: 3009611645
·
FEI: 3009611645
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOTEM CO., LTD.
- Registration Number
- 3009611645
- FEI Number
- 3009611645
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- # 422, Sasang-ro, Sasang-gu
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- Biotem Co., Ltd.
- Operator Number
- 10057313
- Address
- # 422, Sasang-ro, Sasang-gu
- City
- Busan
- State
- KR-26
- Postal Code
- 46925
- Country
- KR
US Agent
- Business Name
- GS GLOBAL USA, INC
- Contact Name
- Seong han Chung
- Address
- 17785 Center Court Dr., Suite 260
- City
- Cerritos
- State
- CA
- ZIP
- 90703
- Country
- US
- [email protected]
- Phone
- 562 7773106
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2018-03-19 |
Proprietary Names
BR Pick-Up Impression Coping
AR_N Transfer Impression Coping
Torque Wrench
AR_N Solid Lab Analog
IR Pick-Up Impression Coping
AR_N Pick-Up Impression Coping
BR Hand Driver
AR_N Hand Driver
AR_N Fixture Lab Analog
IR Fixture Lab Analog
BR Lab Analog
BR Transfer Impression Coping
IR Solid Lab Analog
Transfer Impression Coping
Hand Driver
Solid Lab Analog
Fixture Lab Analog
Pick-Up Impression Coping
Establishment Types
Manufacture Medical Device