Bredent-Products For the Dental Technician Laborat
GermanyFDA applicant, unverified
- Devices
- 3
What Bredent-Products For the Dental Technician Laborat makes
The company produces dental laboratory equipment and materials, including a composite resin system (BRECOMP) for dental restorations and a polymer-based modeling material (DENTAPLAST HOT, Model 16-XXX) for creating dental models. It also offers a digital workflow solution (BREFORMANCE) for dental technicians to optimize laboratory processes.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates in the United States.
Catalogue
Brecomp Ref K052779
Regimes: 510(k) Registry: 510(k)Breformance Ref K052781
Regimes: 510(k) Registry: 510(k)Dentaplast Hot, Model 16-Xxx Ref K052780
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bredent-Products For the Dental Technician Laborat have in the registry?
The registry currently lists 3 devices for Bredent-Products For the Dental Technician Laborat. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bredent-Products For the Dental Technician Laborat's devices?
Among its 3 most recently registered devices, Bredent-Products For the Dental Technician Laborat has devices listed in FDA 510(k) (3 devices).
What risk classes do Bredent-Products For the Dental Technician Laborat's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bredent-Products For the Dental Technician Laborat's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bredent-Products For the Dental Technician Laborat in the registry?
The most recently registered devices listed for Bredent-Products For the Dental Technician Laborat include BRECOMP, BREFORMANCE and DENTAPLAST HOT, MODEL 16-XXX.