Matech, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Matech, Inc. makes
Matech, Inc. manufactures dental impression materials, including non-precious ceramic alloys like HI BOND, DURABOND, CERADIUM, and CERADIUM V, as well as a color-changing alginate product called KROMATICA. The company also produces dental replicas for laboratory use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Matech, Inc. is based in the United States.
Catalogue
Hi Bond Non-Precious Ceramic Alloy Ref K992881
Regimes: 510(k) Registry: 510(k)Kromatica Color Changing Alginate Ref K974894
Regimes: 510(k) Registry: 510(k)Durabond Non-Precious Ceramic Alloy Ref K010069
Regimes: 510(k) Registry: 510(k)Replica Ref K925746
Regimes: 510(k) Registry: 510(k)Ceradium V Non-Precious Ceramic Alloy Ref K993572
Regimes: 510(k) Registry: 510(k)Ceradium Non-Precious Ceramic Alloy Ref K992705
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Matech, Inc. have in the registry?
The registry currently lists 6 devices for Matech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Matech, Inc.'s devices?
Among its 6 most recently registered devices, Matech, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Matech, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Matech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Matech, Inc. in the registry?
The most recently registered devices listed for Matech, Inc. include HI BOND NON-PRECIOUS CERAMIC ALLOY, KROMATICA COLOR CHANGING ALGINATE, DURABOND NON-PRECIOUS CERAMIC ALLOY and REPLICA.