Not currently registered with FDA under this name
Achimhai Medical Corporation
Hwaseong-Si, South Korea. Named as applicant on 3 dental 510(k) clearances between 2017 and 2021. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32017–2021
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Achimhai Medical Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Achimhai Medical Corporation | 3 clearances | 2017–2021 | Below |
| Taiwan | TFDA | Manufacturer | Achimhai Medical Corporation | 1 | 2019–2019 | 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
510(k) clearances
Clearances on which FDA names Achimhai Medical Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Aug 2021 | K200193 | Kisses Plus Implant System | NHA Endosseous Dental Implant Abutment |
| 3 Apr 2018 | K172630 | Kisses Plus Implant System | DZE Root-Form Endosseous Implant |
| 6 Oct 2017 | K170394 | Kisses Mini | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: ACH Medical Co., Ltd. (3).
Sources
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 of the most recent filing, which can be a US agent.