Stephen M Koral, Dmd
Country not established
- Devices
- 2
What Stephen M Koral, Dmd makes
Stephen M Koral, DMD, manufactures dental devices including the CALEX CONDITIONER and NEOCALEX, which are used in oral health applications for conditioning and treating dental surfaces.
These products are regulated under FDA Class I and Class II designations, with clearance via 510(k) submissions. The manufacturer operates in the United States.
Catalogue
Calex Conditioner Ref K010176
Regimes: 510(k) Registry: 510(k)Neocalex Ref K013993
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stephen M Koral, Dmd have in the registry?
The registry currently lists 2 devices for Stephen M Koral, Dmd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stephen M Koral, Dmd's devices?
Among its 2 most recently registered devices, Stephen M Koral, Dmd has devices listed in FDA 510(k) (2 devices).
What risk classes do Stephen M Koral, Dmd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Stephen M Koral, Dmd's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stephen M Koral, Dmd in the registry?
The most recently registered devices listed for Stephen M Koral, Dmd include CALEX CONDITIONER and NEOCALEX.