Not currently registered with FDA under this name
Osstem Implant Co., Ltd. Chair Business
Ansan-Si, South Korea. Named as applicant on 1 dental 510(k) clearance between 2024 and 2024. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12024–2024
- Markets registered in
- 35 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Osstem Implant Co., Ltd. Chair Business 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 | Osstem Implant Co., Ltd. Chair Business | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | OSSTEM IMPLANT Co., Ltd. Chair Business | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Osstem Implant Co Ltd Chair Business | 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 Osstem Implant Co., Ltd. Chair Business as the applicant.
Some of these clearances are listed with FDA today by another company: Osstem Implant Co., Ltd. (1).
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.