Prometex, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Prometex, Inc. makes
Prometex, Inc. manufactures dental materials and diagnostic tools, including resin systems for crowns and bridges, temporary crown and bridge resins, and a laser light for positioning in dental procedures. Their portfolio also includes an audiometer used for hearing screening.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. Their products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Aristee (Resin, Crown And Bridges) Ref K900068
Regimes: 510(k) Registry: 510(k)Audiotester Screening Audiometer Ref K894484
Regimes: 510(k) Registry: 510(k)A2J Mz 44 Laser Light For Positioning Ref K872894
Regimes: 510(k) Registry: 510(k)Aristee (Temporary Crown & Bridge Resin) Ref K892710
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prometex, Inc. have in the registry?
The registry currently lists 4 devices for Prometex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prometex, Inc.'s devices?
Among its 4 most recently registered devices, Prometex, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Prometex, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Prometex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prometex, Inc. in the registry?
The most recently registered devices listed for Prometex, Inc. include ARISTEE (RESIN, CROWN AND BRIDGES), AUDIOTESTER SCREENING AUDIOMETER, A2J MZ 44 LASER LIGHT FOR POSITIONING and ARISTEE (TEMPORARY CROWN & BRIDGE RESIN).