Data / Medical devices / Germany / anax dent GmbH
anax dent GmbH: FDA-registered device maker in Stuttgart Baden-Wurttemberg, Germany, 5 510(k) clearances
anax dent GmbH is registered with the FDA (registration 3007791519) in Stuttgart Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 26, 2012. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007791519
- Address
- Dreifelderstrasse 5, Stuttgart Baden-Wurttemberg, Germany, 70599
- Owner or operator
- anax dent GmbH (10028652)
- Roles
- Manufacturer
- First device listed
- February 20, 2009
- Registered through
- 2026
- Brand names listed
- Acryline, New Outline, PMMA BLANKS, Visco III, anaxBLEND, anaxGLAZE, anaxGUM, anaxPINK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 26, 2012 | K112044 | ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A | EBF | Substantially Equivalent | Anaxdent GmbH | accessdata.fda.gov |
| December 16, 2010 | K102341 | VIPI BLOCK | EBG | Substantially Equivalent | Vipi Industria,Comercio,Exportacao E Importacao DE | accessdata.fda.gov |
| September 28, 2010 | K101710 | LUXATEMP ULTRA /STAR | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| October 26, 2005 | K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | EBI | Substantially Equivalent | Schutz-Dental GmbH | accessdata.fda.gov |
| October 30, 2002 | K023079 | NEW OUTLINE | EBG | Substantially Equivalent | Anaxdent GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
Updated January 26, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.