Britesmile, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Britesmile, Inc. makes
Britesmile, Inc. manufactures cosmetic products designed to conceal dental imperfections, including a masking cream and a barrier material for dental applications.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Britesmile Masking Cream Ref K040797
510(k) 510(k)Britesmile Barrier Material Ref K010935
510(k) 510(k)
Frequently asked questions
How many devices does Britesmile, Inc. have in the registry?
The registry currently lists 2 devices for Britesmile, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Britesmile, Inc.'s devices?
Among its 2 most recently registered devices, Britesmile, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Britesmile, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Britesmile, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Britesmile, Inc. in the registry?
The most recently registered devices listed for Britesmile, Inc. include BRITESMILE MASKING CREAM and BRITESMILE BARRIER MATERIAL.