Not currently registered with FDA under this name
Pointnix Co., Ltd.
Buk-Gu, South Korea. Named as applicant on 1 dental 510(k) clearance between 2023 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12023–2023
- Markets registered in
- 24 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Pointnix 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 | Pointnix Co., Ltd. | 1 clearances | 2023–2023 | Below |
| Taiwan | TFDA | Manufacturer | POINTNIX CO., LTD.PointNix Co., Ltd | 4 | 2009–2014 | 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 Pointnix Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Apr 2023 | K222738 | Point implant system | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: PointImplant 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.