Not currently registered with FDA under this name
Detax GmbH & Co. KG
Ettlingen, Germany. Named as applicant on 4 dental 510(k) clearances between 2000 and 2020. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42000–2020
- Markets registered in
- 529 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Detax GmbH & Co. KG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Detax GmbH & Co. KG | 4 clearances | 2000–2020 | Below |
| Taiwan | TFDA | Manufacturer | DETAX GMBH & CO. KG | 11 | 2005–2021 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DETAX GMBH & CO. KG | 9 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DETAX GmbH & Co. KGDETAX GmbH & Co.Kg | 5 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DETAX GmbH & Co. KG | 4 | 2013–2015 | 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
510(k) clearances
Clearances on which FDA names Detax GmbH & Co. KG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Nov 2020 | K200461 | Freeprint denture | EBI Rebasing Repairing Relining Denture Resin |
| 27 Oct 2020 | K200273 | FREEPRINT temp | EBG Resin Temporary Crown and Bridge |
| 13 Mar 2017 | K162654 | mollosil plus | EBI Rebasing Repairing Relining Denture Resin |
| 16 Feb 2000 | K994012 | TEMPOFIT, MODEL 02693 | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Detax GmbH (4), Aidite (Qinhuangdao) Technology Co., Ltd (2), Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (1), Dentsply Sirona, Inc. (1), Pac-Dent Inc. (1), HEXA Dental (1).
Sources
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 of the most recent filing, which can be a US agent.