FDA Registration
Active
🇰🇷 South Korea
RetroMTA-OrthoMTA II
Reg #: 3009130085
·
FEI: 3009130085
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BioMTA
- Registration Number
- 3009130085
- FEI Number
- 3009130085
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 41, Techno 8-ro, Yuseong-gu
- City
- Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K132825
Owner / Operator
- Firm Name
- BioMTA
- Operator Number
- 10034152
- Address
- 41, Techno 8-ro, Yuseong-gu
- City
- Daejeon
- State
- KR-30
- Postal Code
- 34028
- Country
- KR
- Correspondent
- Jun-sang Yoo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2014-04-14 |
Proprietary Names
RetroMTA-OrthoMTA II
Smart MTA
Establishment Types
Manufacture Medical Device