FDA Registration
Active
🇰🇷 South Korea
MK MEDITECH
Reg #: 3018070878
·
FEI: 3018070878
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- MK MEDITECH
- Registration Number
- 3018070878
- FEI Number
- 3018070878
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2022-04-26 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-12-20 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2021-12-20 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2021-02-18 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2021-12-20 |
Proprietary Names
MK Drill Bit
ATOZ Screwdriver
ATOZ Utility Wire
ATOZ Expander, ATOZ Key, Model ATOZ, Guide ATOZ
ATOZ Mini-Screw
Establishment Types
Manufacture Medical Device