Ergometa
Country not established
- Devices
- 1
What Ergometa makes
Ergometa manufactures dental materials, specifically the Zirkondent line, which includes zirconia-based restorative and prosthetic dental products designed for crowns, bridges, and inlays.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. Zirkondent is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Zirkondent Ref K080146
510(k) 510(k)
Frequently asked questions
How many devices does Ergometa have in the registry?
The registry currently lists 1 device for Ergometa. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ergometa's devices?
Among its 1 most recently registered device, Ergometa has devices listed in FDA 510(k) (1 device).
What risk classes do Ergometa's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ergometa's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ergometa in the registry?
The most recently registered devices listed for Ergometa include ZIRKONDENT.