Sudimplant SA
FranceFDA applicant, unverified FDA FEI 3005643710
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Sudimplant SA makes
Sudimplant SA manufactures dental implants, including the T.B.R. ZIRCONNECT and TBR IDEA CONIC/CONIC systems, designed for osseointegrated fixation in oral and maxillofacial applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
T.B.R. Zirconnect Ref K070935
Regimes: 510(k) Registry: 510(k)Tbr Idea Conic/Conic Ref K050956
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3005643710
- Address
- 24 IMPASSE RENE COUZINET, TOULOUSE Haute-Garonne
Frequently asked questions
How many devices does Sudimplant SA have in the registry?
The registry currently lists 2 devices for Sudimplant SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sudimplant SA's devices?
Among its 2 most recently registered devices, Sudimplant SA has devices listed in FDA 510(k) (2 devices).
What risk classes do Sudimplant SA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sudimplant SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sudimplant SA in the registry?
The most recently registered devices listed for Sudimplant SA include T.B.R. ZIRCONNECT and TBR IDEA CONIC/CONIC.