Candulor USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Candulor USA, Inc. makes
Candulor USA, Inc. manufactures dental devices, including the PHYSIOSTAR NFC—a handheld unit for oral hygiene and periodontal monitoring—and the DIRECT CROWN NATURAL 1, a system for chairside crown fabrication using CAD/CAM technology.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Physiostar Nfc Ref K122852
Regimes: 510(k) Registry: 510(k)Direct Crown Natural 1 Ref K101814
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Candulor USA, Inc. have in the registry?
The registry currently lists 2 devices for Candulor USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Candulor USA, Inc.'s devices?
Among its 2 most recently registered devices, Candulor USA, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Candulor USA, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Candulor USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Candulor USA, Inc. in the registry?
The most recently registered devices listed for Candulor USA, Inc. include PHYSIOSTAR NFC and DIRECT CROWN NATURAL 1.