Cycura Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Cycura Corp. makes
Cycura Corp. manufactures oral diagnostic devices, including the ORALSENSOR for detecting dental caries and the NIGHTGUARD diagnostic appliance for assessing temporomandibular joint disorders.
These products are regulated as Class II and Unclassified devices under FDA 510(k) clearance requirements. The company is based in the United States.
Catalogue
Oralsensor Ref K953257
510(k) 510(k)Nightguard Diagnostic Appliance Ref K955701
510(k) 510(k)
Frequently asked questions
How many devices does Cycura Corp. have in the registry?
The registry currently lists 2 devices for Cycura Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cycura Corp.'s devices?
Among its 2 most recently registered devices, Cycura Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cycura Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cycura Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cycura Corp. in the registry?
The most recently registered devices listed for Cycura Corp. include ORALSENSOR and NIGHTGUARD DIAGNOSTIC APPLIANCE.