Manufacturer registered with FDA
Detax GmbH
ETTLINGEN, Germany. Lists 12 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 96
- 510(k) clearances
- 22022–2025
- Markets registered in
- 11197 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Detax GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Detax GmbH | 2 clearances | 2022–2025 | Below |
| Canada | Health Canada | Registration holder | DETAX GMBH | 53 | 2006–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DETAX GmbH | 29 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Detax GmbH | 23 | 2007–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DETAX GmbH | 23 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Detax GmbH | 21 | 2005–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | DETAX GMBH | 20 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DETAX GMBH | 8 | 2023–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Detax GmbH | 8 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DETAX GmbH | 7 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DETAX GmbHDetax GmbH | 5 | 1999–2024 | 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 Detax 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 |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Freepint denture impact dark reddish pink 1000gfreeprint denture flex pink 1000gfreeprint denture flex pink transparent 1000gFREEPRINT® denture impact pink 1000 gFREEPRINT® denture impact pink-transparent 1000 gRS VIVO Denture Flex pink transparent 1000gRS VIVO Denture Flex transparent 1000gRS VIVO Denture Impact pink 1000gRS VIVO Denture Impact pink transparent 1000gVITA VIONIC® BASE RESIN FLEX clear 1000g 3 moreVITA VIONIC® BASE RESIN FLEX pink transparent 1000gVITA VIONIC® BASE RESIN IMPACT pink 1000gVITA VIONIC® BASE RESIN IMPACT pink-transparent 1000g | 2012 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | FREEPRINT® crown A3,5 1000gFREEPRINT® crown A3,5 500gtempofit premium B1tempofit premium BLVITA VIONIC® DENT RESIN 0M3 1000gVITA VIONIC® DENT RESIN 0M3 500gVITA VIONIC® DENT RESIN A1 1000gVITA VIONIC® DENT RESIN A1 500gVITA VIONIC® DENT RESIN A2 1000gVITA VIONIC® DENT RESIN A2 500g 12 moreVITA VIONIC® DENT RESIN A3 1000gVITA VIONIC® DENT RESIN A3 500gVITA VIONIC® DENT RESIN A3,5 1000gVITA VIONIC® DENT RESIN A3,5 500gVITA VIONIC® DENT RESIN B1 1000gVITA VIONIC® DeNT RESIN B1 500gVITA VIONIC® DENT RESIN B3 1000gVITA VIONIC® DENT RESIN B3 500gVITA VIONIC® DENT RESIN C2 1000gVITA VIONIC® DENT RESIN C2 500gVITA VIONIC® DENT RESIN D3 1000gVITA VIONIC® DENT RESIN D3 500g | 2006 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | FREEPRINT splintmaster flex 1000gFREEPRINT splintmaster taff 1000gPrimeprint Guide 2Primeprint Splint SF 1000gPrimeprint Splint ST 1000gRS VIVO Splint Flex 1000gRS VIVO Splint Hard 1000gVITA VIONIC® TRY-IN RESIN 1000gVITA VIONIC® TRY-IN RESIN A2 500g | 2016 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | dx retainer 1000gdx retainer 5kgFREEPRINT splintmaster flex 1000gFREEPRINT splintmaster taff 1000gPrimeprint Guide 2Primeprint Splint SFPrimeprint Splint ST 1000gRS VIVO Retainer 1000gRS VIVO Retainer 5kg | 2019 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Primeprint Guide 2 | 2019 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | FREEPRINT® crown A3,5 1000gFREEPRINT® crown A3,5 500gVITA VIONIC® DENT RESIN 0M3 1000gVITA VIONIC® DENT RESIN 0M3 500gVITA VIONIC® DENT RESIN A1 1000gVITA VIONIC® DENT RESIN A1 500gVITA VIONIC® DENT RESIN A2 1000gVITA VIONIC® DENT RESIN A2 500gVITA VIONIC® DENT RESIN A3 1000gVITA VIONIC® DENT RESIN A3 500g 10 moreVITA VIONIC® DENT RESIN A3,5 1000gVITA VIONIC® DENT RESIN A3,5 500gVITA VIONIC® DENT RESIN B1 1000gVITA VIONIC® DeNT RESIN B1 500gVITA VIONIC® DENT RESIN B3 1000gVITA VIONIC® DENT RESIN B3 500gVITA VIONIC® DENT RESIN C2 1000gVITA VIONIC® DENT RESIN C2 500gVITA VIONIC® DENT RESIN D3 1000gVITA VIONIC® DENT RESIN D3 500g | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | RS VIVO IBT 1000g | 1995 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 2010 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | — | 2013 |
| Dental CementEMA · Class 2 | Dental cements | Maker | — | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Primeprint Guide 2 | 2016 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | FREEPRINT crown A3,5 1000gFREEPRINT crown A3,5 500gVITA VIONIC® DENT RESIN 0M3 1000gVITA VIONIC® DENT RESIN 0M3 500gVITA VIONIC® DENT RESIN A1 1000gVITA VIONIC® DENT RESIN A1 500gVITA VIONIC® DENT RESIN A2 1000gVITA VIONIC® DENT RESIN A2 500gVITA VIONIC® DENT RESIN A3 1000gVITA VIONIC® DENT RESIN A3 500g 10 moreVITA VIONIC® DENT RESIN A3,5 1000gVITA VIONIC® DENT RESIN A3,5 500gVITA VIONIC® DENT RESIN B1 1000gVITA VIONIC® DENT RESIN B1 500gVITA VIONIC® DENT RESIN B3 1000gVITA VIONIC® DENT RESIN B3 500gVITA VIONIC® DENT RESIN C2 1000gVITA VIONIC® DENT RESIN C2 500gVITA VIONIC® DENT RESIN D3 1000gVITA VIONIC® DENT RESIN D3 500g | 2022 |
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 Detax GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Oct 2025 | K252430 | Freeprint® denture flex | EBI Rebasing Repairing Relining Denture Resin |
| 23 Sep 2022 | K222877 | FREEPRINT crown | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Aidite (Qinhuangdao) Technology Co., Ltd (1), Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (1).
Also lists devices cleared under other names
Detax 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: Detax GmbH & Co. KG (4), Detax GmbH & Co. KG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Nov 2020 | K200461 | Freeprint denture | Detax GmbH & Co. KG | EBI Rebasing Repairing Relining Denture Resin |
| 27 Oct 2020 | K200273 | FREEPRINT temp | Detax GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 13 Mar 2017 | K162654 | mollosil plus | Detax GmbH & Co. KG | EBI Rebasing Repairing Relining Denture Resin |
| 23 Jul 2010 | K100247 | DETAX IMPLANTLINK SEMI | Detax GmbH & Co. KG | EMA Dental Cement |
| 16 Feb 2000 | K994012 | TEMPOFIT, MODEL 02693 | Detax GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DETAX GMBHFDA reg. 9680954 | ETTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9012556). 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.