Is this your brand? Sign in to claim ownership.
Sign in to claim this brandVatech mcis Co., Ltd
US
Last updated May 23, 2026
What Vatech mcis Co., Ltd makes
Vatech mcis Co., Ltd manufactures dental appliance fabrication materials, specializing in ceramic-based products. Their portfolio includes materials used for creating dental restorations and prosthetics, such as crowns, bridges, and inlays, designed for precision and biocompatibility in dental laboratories.
The company’s products are regulated under FDA’s classification system, with devices falling into Class I and Class II categories. These materials are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Vatech mcis Co., Ltd primarily manufacture?
Vatech mcis Co., Ltd specializes in dental appliance fabrication materials, specifically ceramic-based products. These materials are used in dental laboratories to create dental restorations and prosthetics, such as crowns, bridges, and inlays. The focus is on precision and biocompatibility to ensure safe and effective use in dental applications.
Where is Vatech mcis Co., Ltd based?
Vatech mcis Co., Ltd is based in the United States. This location influences its regulatory compliance, particularly with U.S. medical device regulations like those enforced by the FDA.
Which regulatory registries or databases list Vatech mcis Co., Ltd’s devices?
Vatech mcis Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device can be traced and tracked for compliance with U.S. medical device regulations, supporting transparency and accountability in the supply chain.
How are Vatech mcis Co., Ltd’s devices classified under U.S. regulations?
Vatech mcis Co., Ltd’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 688284886
Catalogue (1176)
Page 12 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Perfit ZR | NU 16 A3.5TM W | FDA UDI | Class II | Active |
| Perfit ZR | NU 10 BL2S W | FDA UDI | Class I | Active |
| Perfit ZR | NP 12 C2 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 18 B4SM W | FDA UDI | Class II | Active |
| Perfit ZR | NU 22 A4TM W | FDA UDI | Class II | Active |
| Perfit ZR | NU 18 B2SM W | FDA UDI | Class II | Active |
| Perfit ZR | NU 18 B1 W | FDA UDI | Class II | Active |
| Perfit FS | FH B32 A3.5M | FDA UDI | Class II | Active |
| Perfit ZR | NP 12 A1 W | FDA UDI | Class II | Active |
| Perfit FS | FH B32 C3 | FDA UDI | Class II | Active |
| Perfit ZR | NU 22 C2TM W | FDA UDI | Class II | Active |
| Perfit FS | FH C14 C3M | FDA UDI | Class II | Active |
| Perfit ZR | NA 18 B3 W | FDA UDI | Class II | Active |
| Perfit ZR | NP 30 A2 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 20 B4TM W | FDA UDI | Class II | Active |
| Perfit FS | FH C14 A1M | FDA UDI | Class II | Active |
| Perfit ZR | NU 18 D3SM W | FDA UDI | Class II | Active |
| Perfit ZR | NU 16 A1SM W | FDA UDI | Class II | Active |
| Perfit ZR | NA 25 A2 W | FDA UDI | Class II | Active |
| Perfit ZR | NA 18 C2 W | FDA UDI | Class II | Active |
| Perfit ZR | NA 12 A4 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 14 A2 W | FDA UDI | Class II | Active |
| Perfit ZR | NA 16 C4 W | FDA UDI | Class II | Active |
| Perfit FS | FH I10 B2 | FDA UDI | Class II | Active |
| Perfit ZR | NU 22 B3TM W | FDA UDI | Class II | Active |
| Perfit ZR | NU 25 B3 W | FDA UDI | Class II | Active |
| Perfit ZR | NP 30 C1 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 18 BL3SM W | FDA UDI | Class I | Active |
| Perfit ZR | NU 16 BL3 W | FDA UDI | Class I | Active |
| Chairside Zirconia | FH C16 B4M | FDA UDI | Class II | Active |
| Perfit ZR | NU 12 A2 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 25 BL1S W | FDA UDI | Class I | Active |
| Perfit ZR | NU 16 D3 W | FDA UDI | Class II | Active |
| RAYZir FS | FH C16 C4M | FDA UDI | Class II | Active |
| Perfit ZR | NU 16 A2TM W | FDA UDI | Class II | Active |
| Perfit FS | FH C16 A3M | FDA UDI | Class II | Active |
| Perfit ZR | NA 14 A1 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 25 C3TM W | FDA UDI | Class II | Active |
| Perfit ZR | NU 20 D3 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 14 A3.5 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 16 A3 W | FDA UDI | Class II | Active |
| Perfit ZR | NU 20 D2 W | FDA UDI | Class II | Active |
| RAYZir FS | FH C14 D2M | FDA UDI | Class II | Active |
| Chairside Zirconia | FH C14 D2 | FDA UDI | Class II | Active |
| Perfit ZR | NU 25 C3 W | FDA UDI | Class II | Active |
| RAYZir FS | FH I12 D2 | FDA UDI | Class II | Active |
| Perfit ZR | NA 25 white W | FDA UDI | Class II | Active |
| Perfit ZR | NA 25 C4 W | FDA UDI | Class II | Active |
| Perfit FS | FH C16 white | FDA UDI | Class II | Active |
| Perfit FS | FH B40 A3 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Vatech mcis Co., Ltd. Suwon-si Gyeonggi · KR FEI 3019784699