Data / Medical devices / Handpiece, Air-Powered, Dental / Germany
FDA-registered makers of Handpiece, Air-Powered, Dental in Germany: 7 establishments
7 establishments in Germany are registered with the FDA to make Handpiece, Air-Powered, Dental (product code EFB). 7 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
- Handpiece, Air-Powered, Dental
- Product code
- EFB
- Country
- Germany
Makers of Handpiece, Air-Powered, 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 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 8 | January 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Exporter to the US, Specification developer | 3 | February 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 3 | April 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Kavo Dental GMBH | BIBERACH Baden-Wurttemberg, Germany | Manufacturer | 2 | September 27, 2013 | 0 | 0 | 0 | api.fda.gov |
| MK-dent GmbH | Bargteheide Schleswig-Holstein, Germany | Manufacturer | 2 | October 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| Sycotec GMBH & Co KG | Leutkirch Baden-Wurttemberg, Germany | Contract manufacturer, Specification developer | 1 | October 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Tunap GMBH & Co. KG | Wolfratshausen Bavaria, Germany | Manufacturer | 1 | October 19, 2006 | 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.