Not currently registered with FDA under this name
Biogenesis Co., Ltd.
Changwon-Si, South Korea. Named as applicant on 2 dental 510(k) clearances between 2013 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22013–2015
- Markets registered in
- 49 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Biogenesis Co., Ltd. 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 | Biogenesis Co., Ltd. | 2 clearances | 2013–2015 | Below |
| Taiwan | TFDA | Manufacturer | BIOGENESIS CO., LTD.Biogenesis Co., Ltd. | 5 | 2011–2016 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Biogenesis | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Biogenesis S.R.L | 1 | — | 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 Biogenesis Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Jul 2015 | K142813 | Biogensis Implant System-Kisses | DZE Root-Form Endosseous Implant |
| 13 Mar 2013 | K120089 | BIOGENESIS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: ACH Medical Co., Ltd. (2).
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.