Global Dental Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Global Dental Products, Inc. makes
Global Dental Products, Inc. manufactures dental devices, including CIMOFLUOR—a fluoride-releasing dental material—and INFIBRA Model 1200, a fiber-reinforced composite for dental restorations.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Cimofluor Ref K023888
Regimes: 510(k) Registry: 510(k)Infibra, Model 1200 Ref K061735
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Global Dental Products, Inc. have in the registry?
The registry currently lists 2 devices for Global Dental Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Global Dental Products, Inc.'s devices?
Among its 2 most recently registered devices, Global Dental Products, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Global Dental Products, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Global Dental Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Global Dental Products, Inc. in the registry?
The most recently registered devices listed for Global Dental Products, Inc. include CIMOFLUOR and INFIBRA, MODEL 1200.