Data / Medical devices / Additively Manufactured, Preformed, Resin Denture Tooth / Germany
FDA-registered makers of Additively Manufactured, Preformed, Resin Denture Tooth in Germany: 6 establishments
6 establishments in Germany are registered with the FDA to make Additively Manufactured, Preformed, Resin Denture Tooth (product code PZY). 1 has 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
- Additively Manufactured, Preformed, Resin Denture Tooth
- Product code
- PZY
- Country
- Germany
Makers of Additively Manufactured, Preformed, Resin Denture Tooth in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KG | Bremen, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kulzer GMBH | WEHRHEIM Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro3dure Medical GMBH | Iserlohn North Rhine-Westphalia, Germany | 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.