Fen Dental Mfg., Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Fen Dental Mfg., Inc. makes
Fen Dental Mfg., Inc. manufactures dental impression materials and dental casting alloys, including AGALLOY, DISALLOY, EPSILON, and LAMBDA alloys for dental restorations, as well as the SUNLITE 1275 curing light and CHROMOPRINT chromatic alginate impression material for dental molds.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Agalloy, Disalloy, Epsilon And Lambda Ref K942430
Regimes: 510(k) Registry: 510(k)Sunlite 1275 Ref K951465
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fen Dental Mfg., Inc. have in the registry?
The registry currently lists 3 devices for Fen Dental Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fen Dental Mfg., Inc.'s devices?
Among its 3 most recently registered devices, Fen Dental Mfg., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Fen Dental Mfg., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Fen Dental Mfg., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fen Dental Mfg., Inc. in the registry?
The most recently registered devices listed for Fen Dental Mfg., Inc. include AGALLOY, DISALLOY, EPSILON AND LAMBDA, SUNLITE 1275 and CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL.