Caristo Diagnostics
Country not established
Part of Caristo Diagnostics Ltd
- Devices
- 3
What Caristo Diagnostics makes
Caristo Diagnostics manufactures CariCloud, a digital platform designed for monitoring and managing oral health data, including caries risk assessment and treatment tracking. The system integrates diagnostic tools and patient records to support clinical decision-making in dental settings.
The company’s portfolio is classified under FDA Class II devices and has been authorised through 510(k) clearance. CariCloud is listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
- Registry: GUDID
CaRi-Heart Ref DEN250042
Regimes: De Novo Registry: De NovoCariCloud Ref K200274
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Caristo Diagnostics have in the registry?
The registry currently lists 3 devices for Caristo Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Caristo Diagnostics's devices?
Among its 3 most recently registered devices, Caristo Diagnostics has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Caristo Diagnostics's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Caristo Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Caristo Diagnostics in the registry?
The most recently registered devices listed for Caristo Diagnostics include CaRi-Plaque 1.0, CaRi-Heart and CariCloud.