Unidental Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 2
What Unidental Co., Ltd. makes
Unidental Co., Ltd. manufactures the UNIdental Symphony Implant System, a dental implant solution designed for osseointegrated tooth replacement in the oral and maxillofacial region.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance in the United States. The manufacturer is based in the US.
Catalogue
Cemented Plus Abutment Ref K262207
Regimes: 510(k) Registry: 510(k)UNIdental Symphony Implant System Ref K221315
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unidental Co., Ltd. have in the registry?
The registry currently lists 2 devices for Unidental Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unidental Co., Ltd.'s devices?
Among its 2 most recently registered devices, Unidental Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Unidental Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Unidental Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unidental Co., Ltd. in the registry?
The most recently registered devices listed for Unidental Co., Ltd. include Cemented Plus Abutment and UNIdental Symphony Implant System.