Data / Medical devices / Material, Impression / Germany
FDA-registered makers of Material, Impression in Germany: 14 establishments
14 establishments in Germany are registered with the FDA to make Material, Impression (product code ELW). 10 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Material, Impression
- Product code
- ELW
- Country
- Germany
Makers of Material, Impression in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Complaint file establishment, Manufacturer | 23 | February 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Specification developer | 12 | May 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Kettenbach GMBH & Co KG | ESCHENBURG Hesse, Germany | Manufacturer | 6 | October 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| DMG Chemisch Pharmazeutische Fabrik GMBH | Hamburg, Germany | Manufacturer | 4 | October 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| S & C Polymer GMBH | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | November 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer, Repackager or relabeler | 3 | March 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Dreve Dentamid GMBH | UNNA North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer | 2 | November 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | August 10, 1994 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Specification developer | 1 | April 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | Kamen North Rhine-Westphalia, Germany | Complaint file establishment, Specification developer | 1 | March 30, 2000 | 0 | 0 | 0 | api.fda.gov |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Identa Dental Material GMBH | CUXHAVEN Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kulzer GMBH | WEHRHEIM Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prisman GMBH | Lorsch Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.