Mion International Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Mion International Corp. makes
Mion International Corp. manufactures dental restorative materials, including a glass ionomer cement for dental fillings and a silver amalgam alloy used in dental restorations. The company also produces a dental radiopaque material for cavity preparation.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Mion 525 Ref K926376
Regimes: 510(k) Registry: 510(k)Type I Glass Ionomer Cement Ref K942808
Regimes: 510(k) Registry: 510(k)Amalcoden Ref K915666
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mion International Corp. have in the registry?
The registry currently lists 3 devices for Mion International Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mion International Corp.'s devices?
Among its 3 most recently registered devices, Mion International Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Mion International Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Mion International Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mion International Corp. in the registry?
The most recently registered devices listed for Mion International Corp. include MION 525, TYPE I GLASS IONOMER CEMENT and AMALCODEN.