Data / Medical devices / Positioner, Tooth, Preformed / Germany
FDA-registered makers of Positioner, Tooth, Preformed in Germany: 8 establishments
8 establishments in Germany are registered with the FDA to make Positioner, Tooth, Preformed (product code KMY). 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
- Positioner, Tooth, Preformed
- Product code
- KMY
- Country
- Germany
Makers of Positioner, Tooth, Preformed in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | February 13, 1995 | 0 | 0 | 0 | api.fda.gov |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreve Dentamid GMBH | UNNA North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erkodent Erich Kopp GMBH | PFALZGRAFENWEILER Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forestadent Bernhard Forster GMBH | PFORZHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro3dure Medical GMBH | Iserlohn North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scheu-Dental GMBH | ISERLOHN North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Exporter to the US, 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.