Enamel Pure
Country not established
- Devices
- 3
What Enamel Pure makes
Enamel Pure manufactures dental photo-activated disinfection systems designed to reduce microbial contamination in oral healthcare settings. The LUNE PureHygiene device uses light-based technology to disinfect surfaces and instruments, targeting bacteria and viruses in dental offices and clinics.
The company’s portfolio is regulated under FDA Class II devices and is listed via 510(k) and UDI registrations. Enamel Pure is based in the United States.
Catalogue
LUNE PureHygiene Ref K260138
Regimes: 510(k) Registry: 510(k)- Registry: GUDID
LUNE™ PureHygiene Ref K234085
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enamel Pure have in the registry?
The registry currently lists 3 devices for Enamel Pure. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enamel Pure's devices?
Among its 3 most recently registered devices, Enamel Pure 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 Enamel Pure's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Enamel Pure's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Enamel Pure in the registry?
The most recently registered devices listed for Enamel Pure include LUNE PureHygiene, LUNE™ PureHygiene EN0000-110-00 and LUNE™ PureHygiene.