Data / Medical devices / Mouthguard, Prescription / Germany
FDA-registered makers of Mouthguard, Prescription in Germany: 11 establishments
11 establishments in Germany are registered with the FDA to make Mouthguard, Prescription (product code MQC). 10 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Mouthguard, Prescription
- Product code
- MQC
- Country
- Germany
Makers of Mouthguard, Prescription in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Pro3dure Medical GMBH | Iserlohn North Rhine-Westphalia, Germany | Manufacturer | 3 | August 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 1 | September 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Dentona AG | Dortmund North Rhine-Westphalia, Germany | Manufacturer | 1 | April 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | October 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| DMG Digital Enterprises Se | Hamburg, Germany | Manufacturer | 1 | September 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Erkodent Erich Kopp GMBH | PFALZGRAFENWEILER Baden-Wurttemberg, Germany | Manufacturer | 1 | October 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Forestadent Bernhard Forster GMBH | PFORZHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Merz Dental GMBH | LUETJENBURG Schleswig-Holstein, Germany | Manufacturer | 1 | April 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Natural Esthetics | Fuessen Bavaria, Germany | Exporter to the US, Manufacturer | 1 | April 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer, Repackager or relabeler | 1 | November 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dental Direkt GmbH | Spenge North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.