Alpha-Dent
Country not established
Part of Alphadent NV
Alpha-Dent is a medical device manufacturer, with 7 devices listed in FDA 510(k) (FDA Class II) as of 14 Nov 2026.
- Devices
- 7
Registry facts
- Registries
- FDA 510(k) 7
- Device classes
- FDA Class II 7
- Sites and related companies
What Alpha-Dent makes
Alpha-Dent manufactures dental precision attachments, including bar and sliding types for fixed prosthodontics, as well as tools for fitting and adjusting these attachments. Their portfolio also includes reusable dental burs (steel and diamond), dental mandrels, and root canal post kits for endodontic treatment. Additional offerings include dental brazing alloys for joining metal components in restorative dentistry.
The company’s devices are regulated under the FDA’s UDI system, with products classified as Class I and Class II. These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. Alpha-Dent operates from the United States.
Catalogue
Centrix's Encore Solo Light Activated Resin Core Ref K932828
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ceramax Ref K062504
Regimes: 510(k) Registry: 510(k)Composite Restorative Material/Radiopaque Ref K904812
Regimes: 510(k) Registry: 510(k)Visible Light Cure Composite Dental Restor. Mat. Ref K904813
Regimes: 510(k) Registry: 510(k)Alpha-Dent Core Buildup Paste Ref K932827
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alpha-Dent have in the registry?
The registry currently lists 7 devices for Alpha-Dent. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alpha-Dent's devices?
Among its 7 most recently registered devices, Alpha-Dent has devices listed in FDA 510(k) (7 devices).
What risk classes do Alpha-Dent's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Alpha-Dent's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alpha-Dent in the registry?
The most recently registered devices listed for Alpha-Dent include CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE, CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST, CERAMAX and COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE.