Data / Medical devices / Unit, Operative Dental / Germany
FDA-registered makers of Unit, Operative Dental in Germany: 8 establishments
8 establishments in Germany are registered with the FDA to make Unit, Operative Dental (product code EIA). 4 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
- Unit, Operative Dental
- Product code
- EIA
- Country
- Germany
Makers of Unit, Operative Dental in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer | 2 | July 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 1 | October 15, 1998 | 0 | 0 | 0 | api.fda.gov |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Manufacturer | 1 | June 6, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ritter Concept GMBH | Biberach Baden-Wurttemberg, Germany | Manufacturer | 1 | December 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OraMetrix GmbH | Berlin Brandenburg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAUMEDIC - Muenchberg | Helmbrechts Bavaria, 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.