C. Hafner GmbH & Co.
Country not established
Part of C.HAFNER GmbH + Co. KG
- Devices
- 1
What C. Hafner GmbH & Co. makes
C. Hafner GmbH & Co. manufactures dental casting alloys, specifically the HELIOFORM gold-based alloy used for dental restorations such as crowns and bridges. The alloy is designed for precision casting in dental laboratories to create durable and biocompatible dental prosthetics.
The company’s dental casting alloy is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The product is intended for use in the United States, where it is subject to compliance with FDA requirements for dental materials.
Catalogue
Helioform Gold-Based Alloy Ref K990670
510(k) 510(k)
Frequently asked questions
How many devices does C. Hafner GmbH & Co. have in the registry?
The registry currently lists 1 device for C. Hafner GmbH & Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list C. Hafner GmbH & Co.'s devices?
Among its 1 most recently registered device, C. Hafner GmbH & Co. has devices listed in FDA 510(k) (1 device).
What risk classes do C. Hafner GmbH & Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for C. Hafner GmbH & Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from C. Hafner GmbH & Co. in the registry?
The most recently registered devices listed for C. Hafner GmbH & Co. include HELIOFORM GOLD-BASED ALLOY.