Anaxdent GmbH
Country not established
- Devices
- 2
What Anaxdent GmbH makes
Anaxdent GmbH manufactures dental impression materials, including customizable alginate-based blends (e.g., ANAXBLEND), pre-mixed alginate powders (e.g., ANAXGUM), and dental mock-up models for restorative workflows (e.g., MOCK-UP DIRECT and MOCK-UP DIRECT FLOW). Their portfolio also includes a product line for creating detailed dental outlines (NEW OUTLINE) used in prosthetic fabrication.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
New Outline Ref K023079
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Anaxdent GmbH have in the registry?
The registry currently lists 2 devices for Anaxdent GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Anaxdent GmbH's devices?
Among its 2 most recently registered devices, Anaxdent GmbH has devices listed in FDA 510(k) (2 devices).
What risk classes do Anaxdent GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Anaxdent GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Anaxdent GmbH in the registry?
The most recently registered devices listed for Anaxdent GmbH include ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A and NEW OUTLINE.