FDA Registration
Active
🇰🇷 South Korea
SIMDA CO.,LTD.
Reg #: 3030426160
·
FEI: 3030426160
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIMDA CO.,LTD.
- Registration Number
- 3030426160
- FEI Number
- 3030426160
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 233, Hakgam-daero, Sasang-gu, Busan
- City
- Busan
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K252320
Owner / Operator
- Firm Name
- SIMDA CO.,LTD.
- Operator Number
- 10089691
- Address
- 233, Hakgam-daero, Sasang-gu, Busan
- City
- Busan
- State
- KR-26
- Postal Code
- 46985
- Country
- KR
- Correspondent
- YoungWoo CHA
US Agent
- Business Name
- B&B DENTAL CERAMIC ARTS INC. DBA 3DBioCAD
- Contact Name
- Charles Park
- Address
- 1525 N 4th St
- City
- Renton
- State
- WA
- ZIP
- 98057
- Country
- US
- [email protected]
- Phone
- 206 7153999
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-12-21 |
Proprietary Names
Scan Body
Lab Analog
SIMDA Abutment
Establishment Types
Manufacture Medical Device