Enamelite, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Enamelite, LLC makes
Enamelite, LLC manufactures dental ceramic spray glazes, including the NOVA Ceramic Spray Glaze for dental restorations and the Tru-Paque opaque porcelain for enhanced opacity. The company also produces the Enamelite AcrySeal Spray Sealant, designed for sealing dental acrylic surfaces.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Enamelite Acryseal Spray Sealant Ref K093019
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enamelite, LLC have in the registry?
The registry currently lists 2 devices for Enamelite, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enamelite, LLC's devices?
Among its 2 most recently registered devices, Enamelite, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Enamelite, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Enamelite, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Enamelite, LLC in the registry?
The most recently registered devices listed for Enamelite, LLC include NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN and ENAMELITE ACRYSEAL SPRAY SEALANT.