Global Dental Direct, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Global Dental Direct, Inc. makes
Global Dental Direct, Inc. manufactures dental handpieces, specifically the GDCH-2000 model, designed for use in dental procedures requiring high-speed rotation and precision.
The company’s portfolio is regulated under FDA Class I devices and includes products listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Model Gdch-2000 Ref K092851
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Global Dental Direct, Inc. have in the registry?
The registry currently lists 1 device for Global Dental Direct, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Global Dental Direct, Inc.'s devices?
Among its 1 most recently registered device, Global Dental Direct, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Global Dental Direct, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Global Dental Direct, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Global Dental Direct, Inc. in the registry?
The most recently registered devices listed for Global Dental Direct, Inc. include MODEL GDCH-2000.