Not currently registered with FDA under this name
Vatech Acucera, Inc.
Yongin-Si, South Korea. Named as applicant on 4 dental 510(k) clearances between 2021 and 2022. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42021–2022
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Vatech Acucera, Inc. 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 | Vatech Acucera, Inc. | 4 clearances | 2021–2022 | Below |
| Australia | TGA | Manufacturer | Vatechacucera Inc | 2 | 2022–2022 | 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 Vatech Acucera, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Oct 2022 | K222686 | Perfit FS Dental Zirconia Fully Sintered Block | EIH Porcelain Powder |
| 24 Jun 2021 | K203590 | Perfit FS Dental Zirconia Fully Sintered Block | EIH Porcelain Powder |
| 5 Apr 2021 | K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | EIH Porcelain Powder |
| 8 Mar 2021 | K203351 | Perfit ZR HT Dental Zirconia blank | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Vatech mcis Co., Ltd. (4).
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.