Amdent AB
SwedenFDA applicant, unverified
- Devices
- 1
What Amdent AB makes
Amdent AB manufactures dental polishing and scaling instruments, including the AMDENT 2030, designed for professional dental hygiene procedures.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices and is listed in the US regulatory system.
Catalogue
Amdent 2030, Polisher/Scaler Ref K920328
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amdent AB have in the registry?
The registry currently lists 1 device for Amdent AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amdent AB's devices?
Among its 1 most recently registered device, Amdent AB has devices listed in FDA 510(k) (1 device).
What risk classes do Amdent AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Amdent AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amdent AB in the registry?
The most recently registered devices listed for Amdent AB include AMDENT 2030, POLISHER/SCALER.