Novocol Inc. Dba Septodont and Confi-Dental Produc
United StatesFDA applicant, unverified
- Devices
- 2
What Novocol Inc. Dba Septodont and Confi-Dental Produc makes
Novocol Inc. (dba Septodont and Confi-Dental) manufactures dental restorative materials, including dual-cure core build-up composites like Granitec and N’Durance Dimer, as well as BPA-free pit and fissure sealants for preventive dental care.
These products are classified as Class II medical devices and are authorised via the FDA’s 510(k) pathway. The company operates under US regulatory oversight.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Bpa-Free Pit And Fissure Sealant Ref K110058
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novocol Inc. Dba Septodont and Confi-Dental Produc have in the registry?
The registry currently lists 2 devices for Novocol Inc. Dba Septodont and Confi-Dental Produc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novocol Inc. Dba Septodont and Confi-Dental Produc's devices?
Among its 2 most recently registered devices, Novocol Inc. Dba Septodont and Confi-Dental Produc has devices listed in FDA 510(k) (2 devices).
What risk classes do Novocol Inc. Dba Septodont and Confi-Dental Produc's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Novocol Inc. Dba Septodont and Confi-Dental Produc's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novocol Inc. Dba Septodont and Confi-Dental Produc in the registry?
The most recently registered devices listed for Novocol Inc. Dba Septodont and Confi-Dental Produc include GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE and BPA-FREE PIT AND FISSURE SEALANT.