Data / Medical devices / Resin, Denture, Relining, Repairing, Rebasing / Germany
FDA-registered makers of Resin, Denture, Relining, Repairing, Rebasing in Germany: 20 establishments
20 establishments in Germany are registered with the FDA to make Resin, Denture, Relining, Repairing, Rebasing (product code EBI). 17 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
- Resin, Denture, Relining, Repairing, Rebasing
- Product code
- EBI
- Country
- Germany
Makers of Resin, Denture, Relining, Repairing, Rebasing in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer, Repackager or relabeler | 8 | June 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Repackager or relabeler, Specification developer | 6 | May 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 3 | October 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 2 | April 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| DMG Chemisch Pharmazeutische Fabrik GMBH | Hamburg, Germany | Manufacturer | 2 | September 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| Merz Dental GMBH | LUETJENBURG Schleswig-Holstein, Germany | Manufacturer | 2 | September 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| S & C Polymer GMBH | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | June 26, 2001 | 0 | 0 | 0 | api.fda.gov |
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 2 | November 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Bredent GMBH & Co.kg | SENDEN Bavaria, Germany | Manufacturer | 1 | December 21, 2005 | 0 | 0 | 0 | api.fda.gov |
| Candulor Dental GmbH | Rielasingen-Worblingen Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 1 | October 17, 1991 | 0 | 0 | 0 | api.fda.gov |
| Degudent GMBH | HANAU Hesse, Germany | Manufacturer | 1 | December 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Dreve Dentamid GMBH | UNNA North Rhine-Westphalia, Germany | Manufacturer | 1 | November 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dental Direkt GmbH | Spenge North Rhine-Westphalia, Germany | Manufacturer | 1 | June 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kettenbach GMBH & Co KG | ESCHENBURG Hesse, Germany | Manufacturer | 1 | November 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Pro3dure Medical GMBH | Iserlohn North Rhine-Westphalia, Germany | Manufacturer | 1 | May 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Schuetz Dental GMBH | ROSBACH Hesse, Germany | Manufacturer | 1 | October 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| anax dent GmbH | Stuttgart Baden-Wurttemberg, Germany | Manufacturer | 1 | October 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| DMG Digital Enterprises Se | Hamburg, Germany | 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 |
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.