FDA Registration
Active
🇰🇷 South Korea
ATOZ Mini-Screw(MKS-1608, MKS-1609, MKS-1610, MKS-1611, MKS-1612, MKS-1613, MKS-1614, MKS-1615, MKS-1616)
Reg #: 3018070878
·
FEI: 3018070878
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MK MEDITECH
- Registration Number
- 3018070878
- FEI Number
- 3018070878
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room # 511, 54, Changeop-ro, Sujeong-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K210559
Owner / Operator
- Firm Name
- MK Meditech
- Operator Number
- 10080664
- Address
- Room # 511, 54, Changeop-ro, Sujeong-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13449
- Country
- KR
- Correspondent
- Minsu Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2021-12-20 |
Proprietary Names
ATOZ Mini-Screw(MKS-1608, MKS-1609, MKS-1610, MKS-1611, MKS-1612, MKS-1613, MKS-1614, MKS-1615, MKS-1616)
Establishment Types
Manufacture Medical Device