W.C. Heraeus GmbH
GermanyFDA 510(k) applicant, unverified
- Devices
- 2
What W.C. Heraeus GmbH makes
W.C. Heraeus GmbH manufactures dental curing lights, including the HERACURE LS 500 and HANAULUX® 2000 series, designed for polymerizing composite restorative materials in clinical settings.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Heracure Ls 500 Ref K875078
510(k) 510(k)Hanaulux(R) 2000 Ref K895715
510(k) 510(k)
Frequently asked questions
How many devices does W.C. Heraeus GmbH have in the registry?
The registry currently lists 2 devices for W.C. Heraeus GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list W.C. Heraeus GmbH's devices?
Among its 2 most recently registered devices, W.C. Heraeus GmbH has devices listed in FDA 510(k) (2 devices).
What risk classes do W.C. Heraeus GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for W.C. Heraeus GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from W.C. Heraeus GmbH in the registry?
The most recently registered devices listed for W.C. Heraeus GmbH include HERACURE LS 500 and HANAULUX(R) 2000.