Data / Medical devices / South Korea / Vatech mcis Co., Ltd.
Vatech mcis Co., Ltd.: FDA-registered device maker in Suwon-si Gyeonggi, South Korea, 5 510(k) clearances
Vatech mcis Co., Ltd. is registered with the FDA (registration 3019784699) in Suwon-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated June 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019784699
- Address
- 38, Saneop-ro 155beon-gil, Gwonseon-gu, Suwon-si Gyeonggi, South Korea, 16648
- Owner or operator
- Vatech mcis Co., Ltd. (10031602)
- Roles
- Manufacturer
- First device listed
- July 13, 2021
- Registered through
- 2026
- Brand names listed
- Chairside Zirconia, Perfit CL, Perfit FS, Perfit FS Dental Zirconia Fully Sintered Block, Perfit ZR HT Dental Zirconia blank, Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank, RAYZir FS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 20, 2023 | K223029 | Perfit CL | EIH | Substantially Equivalent | Vatech Mcis Co., Ltd. | accessdata.fda.gov |
| October 6, 2022 | K222686 | Perfit FS Dental Zirconia Fully Sintered Block | EIH | Substantially Equivalent | Vatech Acucera, Inc. | accessdata.fda.gov |
| June 24, 2021 | K203590 | Perfit FS Dental Zirconia Fully Sintered Block | EIH | Substantially Equivalent | Vatech Acucera, Inc. | accessdata.fda.gov |
| April 5, 2021 | K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | EIH | Substantially Equivalent | Vatech Acucera, Inc. | accessdata.fda.gov |
| March 8, 2021 | K203351 | Perfit ZR HT Dental Zirconia blank | EIH | Substantially Equivalent | Vatech Acucera, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.