Data / Medical devices / Denture, Plastic, Teeth / Germany
FDA-registered makers of Denture, Plastic, Teeth in Germany: 7 establishments
7 establishments in Germany are registered with the FDA to make Denture, Plastic, Teeth (product code ELM). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Denture, Plastic, Teeth
- Product code
- ELM
- Country
- Germany
Makers of Denture, Plastic, Teeth 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, Specification developer | 2 | May 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Merz Dental GMBH | LUETJENBURG Schleswig-Holstein, Germany | Manufacturer | 2 | May 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Bredent GMBH & Co.kg | SENDEN Bavaria, Germany | Manufacturer | 1 | September 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Gebdi Dental Products GMBH | Engen Baden-Wurttemberg, Germany | Specification developer | 1 | November 24, 2009 | 0 | 0 | 0 | api.fda.gov |
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | March 2, 1992 | 0 | 0 | 0 | api.fda.gov |
| Kulzer GMBH | WASSERBURG Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Voco GMBH | CUXHAVEN Lower Saxony, 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.