Austenal Dental, Inc.
United StatesFDA applicant, unverified
- Devices
- 19
What Austenal Dental, Inc. makes
Austenal Dental, Inc. manufactures dental materials for prosthodontics, including modified acrylic denture resins, silver solders, and denture base, relining, repairing, and rebasing resins. Their portfolio also includes dental casting alloys such as Vitallium, palladium-based alloys for porcelain-metal restorations, and nickel-chromium porcelain-fused-to-metal alloys. Specialized components like overdenture stud attachments and dental wires are also produced.
The company’s products are regulated under FDA Class I and Class II devices, with many authorised via the 510(k) pathway. These materials are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Austenal Dental, Inc. have in the registry?
The registry currently lists 19 devices for Austenal Dental, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Austenal Dental, Inc.'s devices?
Among its 19 most recently registered devices, Austenal Dental, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Austenal Dental, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Austenal Dental, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Austenal Dental, Inc. in the registry?
The most recently registered devices listed for Austenal Dental, Inc. include AUSTENAL MODIFIED ACRYLIC DENTURE RESIN, WHITE SILVER SOLDER AND YELLOW SILVER SOLDER, BASE, DENTURE, RELINING, REPAIRING, REBASING, RESIN and AUSTENAL DENTAL COMPOSITE RESIN.