Data / Medical devices / Agent, Tooth Bonding, Resin / Germany
FDA-registered makers of Agent, Tooth Bonding, Resin in Germany: 14 establishments
14 establishments in Germany are registered with the FDA to make Agent, Tooth Bonding, Resin (product code KLE). 11 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Agent, Tooth Bonding, Resin
- Product code
- KLE
- Country
- Germany
Makers of Agent, Tooth Bonding, Resin in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer | 8 | August 1, 2014 | 0 | 1 | 0 | api.fda.gov |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 7 | October 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Specification developer | 5 | July 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| S & C Polymer GMBH | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | July 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY DETREY GmbH | KONSTANZ Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 2 | September 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| DMG Chemisch Pharmazeutische Fabrik GMBH | Hamburg, Germany | Manufacturer | 2 | July 11, 2013 | 0 | 0 | 0 | api.fda.gov |
| Kettenbach GMBH & Co KG | ESCHENBURG Hesse, Germany | Manufacturer | 2 | October 9, 2019 | 0 | 0 | 0 | api.fda.gov |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 1 | October 21, 2005 | 0 | 0 | 0 | api.fda.gov |
| Kulzer GMBH | WEHRHEIM Hesse, Germany | Contract manufacturer, Manufacturer | 1 | December 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Schuetz Dental GMBH | ROSBACH Hesse, Germany | Manufacturer | 1 | June 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | February 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Identa Dental Material GMBH | CUXHAVEN Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MANI MEDICAL GERMANY GmbH | Rosbach Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| medmix Deutschland GmbH | Kiel Schleswig-Holstein, 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.