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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer, Repackager or relabeler8June 23, 2023000api.fda.gov
Kulzer GMBHHANAU Hesse, GermanyExporter to the US, Repackager or relabeler, Specification developer6May 5, 2021000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyManufacturer3October 30, 2025000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer2April 6, 2023000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer2September 22, 1999000api.fda.gov
Merz Dental GMBHLUETJENBURG Schleswig-Holstein, GermanyManufacturer2September 15, 2014000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer, Manufacturer, Repackager or relabeler2June 26, 2001000api.fda.gov
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler2November 16, 2020000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer1December 21, 2005000api.fda.gov
Candulor Dental GmbHRielasingen-Worblingen Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer1October 17, 1991000api.fda.gov
Degudent GMBHHANAU Hesse, GermanyManufacturer1December 18, 2018000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyManufacturer1November 19, 2020000api.fda.gov
Dental Direkt GmbHSpenge North Rhine-Westphalia, GermanyManufacturer1June 23, 2023000api.fda.gov
Kettenbach GMBH & Co KGESCHENBURG Hesse, GermanyManufacturer1November 13, 1998000api.fda.gov
Pro3dure Medical GMBHIserlohn North Rhine-Westphalia, GermanyManufacturer1May 5, 2021000api.fda.gov
Schuetz Dental GMBHROSBACH Hesse, GermanyManufacturer1October 26, 2005000api.fda.gov
anax dent GmbHStuttgart Baden-Wurttemberg, GermanyManufacturer1October 26, 2005000api.fda.gov
DMG Digital Enterprises SeHamburg, GermanyManufacturer0000api.fda.gov
Identa Dental Material GMBHCUXHAVEN Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Kulzer GMBHWEHRHEIM Hesse, GermanyContract manufacturer0000api.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.