Manufacturer registered with FDA
Vatech mcis Co., Ltd.
Suwon-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 12023–2023
- Markets registered in
- 511 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Vatech mcis 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 | Manufacturer | Vatech mcis Co., Ltd. | 1 clearances | 2023–2023 | Below |
| Canada | Health Canada | Registration holder | VATECH MCIS CO., LTD | 5 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Vatech mcis Co., Ltd.Vatech mcis | 3 | 2020–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | VATECH MCIS CO., LTD. | 2 | 2023–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Vatech mcis Co Ltd | 1 | 2024–2024 | 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
Devices listed with FDA
What Vatech mcis Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Chairside ZirconiaPerfit CLPerfit FSPerfit FS Dental Zirconia Fully Sintered BlockPerfit ZR HT Dental Zirconia blankPerfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blankRAYZir FS | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Vatech mcis Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Vatech Acucera, Inc. (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Oct 2022 | K222686 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | EIH Porcelain Powder |
| 24 Jun 2021 | K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | EIH Porcelain Powder |
| 5 Apr 2021 | K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | Vatech Acucera, Inc. | EIH Porcelain Powder |
| 8 Mar 2021 | K203351 | Perfit ZR HT Dental Zirconia blank | Vatech Acucera, Inc. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Vatech mcis Co., Ltd.FDA reg. 3019784699 | Suwon-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031602). 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.