Data / Medical devices / South Korea / MK Meditech
MK Meditech: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 1 510(k) clearance
MK Meditech is registered with the FDA (registration 3018070878) in Seongnam-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018070878
- Address
- Room # 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si Gyeonggi, South Korea, 13449
- Owner or operator
- MK Meditech (10080664)
- Roles
- Manufacturer
- First device listed
- February 18, 2021
- Registered through
- 2026
- Brand names listed
- ATOZ Expander, ATOZ Key, Model ATOZ, Guide ATOZ, ATOZ Mini-Screw, ATOZ Screwdriver, ATOZ Utility Wire, MK Drill Bit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Manufacturer | accessdata.fda.gov |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2021 | K210559 | ATOZ Mini-Screw | OAT | Substantially Equivalent | Mk Meditech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Implant, Endosseous, Orthodontic
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Non-Irrigation Endosseous Dental Implant Drill Bits
- All makers of Retainer, Screw Expansion, Orthodontic
Updated December 19, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.