Heka Dental A/S
DenmarkFDA applicant, unverified
- Devices
- 1
What Heka Dental A/S makes
Heka Dental A/S manufactures the UnicLine Mobile, a portable dental device designed for intraoral imaging and diagnostic procedures.
The UnicLine Mobile is classified as a Class I medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
UnicLine Mobile Ref K150490
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heka Dental A/S have in the registry?
The registry currently lists 1 device for Heka Dental A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heka Dental A/S's devices?
Among its 1 most recently registered device, Heka Dental A/S has devices listed in FDA 510(k) (1 device).
What risk classes do Heka Dental A/S's devices fall under?
Among its 1 most recently registered device, the classes recorded for Heka Dental A/S's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Heka Dental A/S in the registry?
The most recently registered devices listed for Heka Dental A/S include UnicLine Mobile.