Manufacturer registered with FDA
anax dent GmbH
Stuttgart, Germany. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 8
- 510(k) clearances
- 22002–2012
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name anax dent GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | anax dent GmbH | 2 clearances | 2002–2012 | Below |
| South Korea | MFDS | Manufacturer | anaxDENT GmbHanaxdent GmbH | 2 | 2013–2013 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What anax dent GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | anaxGLAZENew OutlinePMMA BLANKSVisco III | 2009 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | anaxBLENDanaxGUManaxPINK | 2012 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Acryline | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names anax dent GmbH as the applicant.
Also lists devices cleared under other names
anax dent GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Vipi Industria,Comercio,Exportacao E Importacao DE (1), Dmg USA, Inc. (1), Schutz Dental GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Dec 2010 | K102341 | VIPI BLOCK | Vipi Industria,Comercio,Exportacao E Importacao DE | EBG Resin Temporary Crown and Bridge |
| 28 Sep 2010 | K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 26 Oct 2005 | K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | Schutz Dental GmbH | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| anax dent GmbHFDA reg. 3007791519 | Stuttgart Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028652). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.