Cariescan, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 2
What Cariescan, Ltd. makes
Cariescan, Ltd. manufactures the Cariescan PRO, a dental imaging device designed for detecting early-stage dental caries in patients, and the Remote View Software, a companion tool for remote analysis and monitoring of imaging results. These products are intended for use in clinical settings to assist dentists in diagnosing tooth decay before it progresses.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where Cariescan, Ltd. is based.
Catalogue
Cariescan Pro Ref K090598
Regimes: 510(k) Registry: 510(k)Remote View Software Ref K111321
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cariescan, Ltd. have in the registry?
The registry currently lists 2 devices for Cariescan, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cariescan, Ltd.'s devices?
Among its 2 most recently registered devices, Cariescan, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cariescan, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cariescan, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cariescan, Ltd. in the registry?
The most recently registered devices listed for Cariescan, Ltd. include CARIESCAN PRO and REMOTE VIEW SOFTWARE.