Manufacturer registered with FDA
MK Meditech
Seongnam-si, South Korea. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 12021–2021
- Markets registered in
- 215 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name MK Meditech as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | MK Meditech | 1 clearances | 2021–2021 | Below |
| Canada | Health Canada | Registration holder | M.K. MEDITECH CO., LTD. | 15 | 2001–2008 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What MK Meditech currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | ATOZ Expander, ATOZ Key, Model ATOZ, Guide ATOZ | 2021 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | ATOZ Utility Wire | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ATOZ Screwdriver | 2021 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | ATOZ Mini-Screw | 2021 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | MK Drill Bit | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MK MEDITECHFDA reg. 3018070878 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10080664). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.