Vatech Acucera, Inc.
South KoreaFDA applicant, unverified
- Devices
- 4
What Vatech Acucera, Inc. makes
Vatech Acucera, Inc. manufactures dental zirconia blanks and fully sintered zirconia blocks used in dental restorations, including crowns and bridges. These products are designed for milling and fabrication in dental laboratories.
The company’s portfolio is regulated as Class II medical devices in the US, with products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Perfit ZR HT Dental Zirconia blank Ref K203351
Regimes: 510(k) Registry: 510(k)Perfit FS Dental Zirconia Fully Sintered Block Ref K203590
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Perfit FS Dental Zirconia Fully Sintered Block Ref K222686
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Vatech Acucera, Inc. have in the registry?
The registry currently lists 4 devices for Vatech Acucera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vatech Acucera, Inc.'s devices?
Among its 4 most recently registered devices, Vatech Acucera, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Vatech Acucera, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Vatech Acucera, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vatech Acucera, Inc. in the registry?
The most recently registered devices listed for Vatech Acucera, Inc. include Perfit ZR HT Dental Zirconia blank, Perfit FS Dental Zirconia Fully Sintered Block and Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank.