Glidewell Laboratories
Country not established
- Devices
- 3
What Glidewell Laboratories makes
Glidewell Laboratories manufactures dental restorative materials, including ceramic and zirconia-based systems like PRISMATIK CERAMIC and PRISMATIK CLINICAL ZIRCONIA, as well as noise-reducing dental materials such as SILENTNITE.
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Prismatik Ceramic Ref K050144
Regimes: 510(k) Registry: 510(k)Prismatik Clinical Zirconia Ref K060104
Regimes: 510(k) Registry: 510(k)Silentnite Ref K972424
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Glidewell Laboratories have in the registry?
The registry currently lists 3 devices for Glidewell Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glidewell Laboratories's devices?
Among its 3 most recently registered devices, Glidewell Laboratories has devices listed in FDA 510(k) (3 devices).
What risk classes do Glidewell Laboratories's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Glidewell Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Glidewell Laboratories in the registry?
The most recently registered devices listed for Glidewell Laboratories include PRISMATIK CERAMIC, PRISMATIK CLINICAL ZIRCONIA and SILENTNITE.