Manufacturer registered with FDA
Dreve Dentamid GmbH
UNNA, Germany. Lists 11 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 27
- 510(k) clearances
- 62017–2025
- Markets registered in
- 8164 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Dreve Dentamid 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 | Dreve Dentamid GmbH | 6 clearances | 2017–2025 | Below |
| South Korea | MFDS | Manufacturer | Dreve Dentamid GmbHDREVE-DENTAMID GMBH · DREVE DENTAMID GmbH · +1 | 69 | 1998–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DREVE DENTAMID GMBHDREVE-DENTAMID GMBH · Dreve Dentamid GmbH | 25 | 2005–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Dreve Dentamid GmbH | 19 | 2004–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dreve Dentamid GmbH | 19 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dreve Dentamid GmbH | 17 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DREVE DENTAMID GMBH | 13 | 2003–2026 | Pure Global AI |
| China | NMPA | Registration holder | 德威医疗公司Dreve Dentamid GmbH | 2 | — | 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 Dreve Dentamid 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 |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | Dynax clearDynax heavy bodyDynax lightDynax monoDynax puttyStoneBite, StoneBite scan | 2012 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | NanoVarnishPlaquit | 2018 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Fixtemp C&B 4:1 | 2024 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | DrufoplastFotoDent IBTFotoDent tray2 | 2010 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | FotoDent denture | 2021 |
| Shellac Base PlateEEA · Class 1 | — | Maker | FotoDent TryIn | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Application tipsMixing tipsTips | 2015 |
| Dental CementEMA · Class 2 | Dental cements | Maker | — | 2015 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | BioBleach hart/softBiolonDrufolen HDrufosoftDrufosoft proKombiplastOdontosil 2K LackOdontosil 50/60 | 2004 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | FotoDent guide | 2015 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Primeprint Direct Aligner | 2025 |
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 Dreve Dentamid GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Nov 2025 | K250739 | Primeprint Direct Aligner | NXC Sequential Aligner |
| 19 Nov 2020 | K200580 | FotoDent denture | EBI Rebasing Repairing Relining Denture Resin |
| 7 Nov 2019 | K190571 | StoneBite and StoneBite scan | ELW Impression Material |
| 13 Apr 2018 | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | ELW Impression Material |
| 5 Apr 2018 | K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | EBD Resin Filling Material Coating |
| 13 Dec 2017 | K171729 | Fixtemp C&B | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Innovation MediTech GmbH (1).
Also lists devices cleared under other names
Dreve Dentamid 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: Dreve Denatmid GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 May 2024 | K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DREVE DENTAMID GMBHFDA reg. 1000486347 | UNNA North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9042374). 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.