Austenal, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Austenal, Inc. makes
Austenal, Inc. manufactures dental casting alloys, including Vitallium 2000 and cobalt-chrome alloys, as well as denture base materials like Myerson’s Permasoft and Economy reline materials. Their portfolio also includes denture teeth, electroforming systems such as the Midas Gold, and dental casting systems like DC Titan, DC Cristal, and DC Zirkon. These products are designed for dental prosthetics and restorative procedures.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database. Austenal, Inc. is based in the United States.
Catalogue
Dc Titan Ref K001798
Regimes: 510(k) Registry: 510(k)Myerson's Permasoft Soft Reline Material Ref K933468
Regimes: 510(k) Registry: 510(k)Myerson Ir Denture Base Ref K954810
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Dc - Cristal Ref K011674
Regimes: 510(k) Registry: 510(k)Myerson's Economy Denture Base Material Ref K970522
Regimes: 510(k) Registry: 510(k)Dc Zirkon Ref K001815
Regimes: 510(k) Registry: 510(k)Denture Plastic Teeth Ref K924526
Regimes: 510(k) Registry: 510(k)Dc-Tell Ref K001799
Regimes: 510(k) Registry: 510(k)Midas Gold Electroforming System Ref K955509
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Austenal, Inc. have in the registry?
The registry currently lists 10 devices for Austenal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Austenal, Inc.'s devices?
Among its 10 most recently registered devices, Austenal, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Austenal, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Austenal, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Austenal, Inc. in the registry?
The most recently registered devices listed for Austenal, Inc. include DC TITAN, MYERSON'S PERMASOFT SOFT RELINE MATERIAL, MYERSON IR DENTURE BASE and VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY.