Qserve America, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Qserve America, Inc. makes
Qserve America, Inc. manufactures dental aligners, including the CLEARPATH ALIGNER, and custom-sized medical devices such as the MEDISIZE RED and MEDISIZE BLUE, designed for precise sizing applications in healthcare settings.
These products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company operates from the United States.
Catalogue
Clearpath Aligner Ref K123514
Regimes: 510(k) Registry: 510(k)Medisize Red And Medisize Blue Ref K110246
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Qserve America, Inc. have in the registry?
The registry currently lists 2 devices for Qserve America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qserve America, Inc.'s devices?
Among its 2 most recently registered devices, Qserve America, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Qserve America, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Qserve America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qserve America, Inc. in the registry?
The most recently registered devices listed for Qserve America, Inc. include CLEARPATH ALIGNER and MEDISIZE RED AND MEDISIZE BLUE.