Dentronic AB
SwedenFDA 510(k) applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Dentronic AB makes
Dentronic AB manufactures the DENZIR, a dental device designed for intraoral imaging and diagnostic procedures, enabling high-resolution imaging of oral and maxillofacial structures.
The DENZIR is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Denzir Ref K984201
510(k) 510(k)
FDA establishments
- Dentronic San Leandro, CA · US FEI 3045321555
Frequently asked questions
How many devices does Dentronic AB have in the registry?
The registry currently lists 1 device for Dentronic AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dentronic AB's devices?
Among its 1 most recently registered device, Dentronic AB has devices listed in FDA 510(k) (1 device).
What risk classes do Dentronic AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Dentronic AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dentronic AB in the registry?
The most recently registered devices listed for Dentronic AB include DENZIR.
Which FDA establishments are linked to Dentronic AB?
1 FDA establishment is linked to Dentronic AB in the registry; they are listed on the company page.