FDA Registration
Active
🇰🇷 South Korea
Chemi-SiL LB
Reg #: 3032435508
·
FEI: 3032435508
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- B&E KOREA CO., LTD.
- Registration Number
- 3032435508
- FEI Number
- 3032435508
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 995-16, Baran-ro, Jeongnam-myeon
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K233954
Owner / Operator
- Firm Name
- B&E KOREA Co., Ltd.
- Operator Number
- 10091760
- Address
- 995-16, Baran-ro, Jeongnam-myeon
- City
- Hwaseong-si
- State
- Gyeonggi
- Postal Code
- 18515
- Country
- KR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2024-10-31 |
Proprietary Names
Chemi-SiL LB
Chemi-SiL HB
Chemi-SiL Bite-Blu
Establishment Types
Manufacture Medical Device