Dental Direkt of Amerika UG (Haftungsbeschraenkt)
GermanyFDA applicant, unverified
- Devices
- 2
What Dental Direkt of Amerika UG (Haftungsbeschraenkt) makes
Dental Direkt of Amerika produces dental composite filling materials, including standard and colored variants for restorative procedures, as well as translucent versions for specific applications.
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Dd Bio Z And Dd Bio Z - Transpa Ref K093748
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dental Direkt of Amerika UG (Haftungsbeschraenkt) have in the registry?
The registry currently lists 2 devices for Dental Direkt of Amerika UG (Haftungsbeschraenkt). Devices recorded under merged duplicate company entries are counted once.
Which registries list Dental Direkt of Amerika UG (Haftungsbeschraenkt)'s devices?
Among its 2 most recently registered devices, Dental Direkt of Amerika UG (Haftungsbeschraenkt) has devices listed in FDA 510(k) (2 devices).
What risk classes do Dental Direkt of Amerika UG (Haftungsbeschraenkt)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dental Direkt of Amerika UG (Haftungsbeschraenkt)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dental Direkt of Amerika UG (Haftungsbeschraenkt) in the registry?
The most recently registered devices listed for Dental Direkt of Amerika UG (Haftungsbeschraenkt) include DD Bio Z, DD Bio ZX(square), DD BioZX(square) color and DD BIO Z AND DD BIO Z - TRANSPA.