Data / Medical devices / Germany / Gebdi Dental Products GMBH
Gebdi Dental Products GMBH: FDA-registered device maker in Engen Baden-Wurttemberg, Germany, 1 510(k) clearance
Gebdi Dental Products GMBH is registered with the FDA (registration 3002727993) in Engen Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 24, 2009. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3002727993
- Address
- Industriestr. 3a, Engen Baden-Wurttemberg, Germany, 78234
- Owner or operator
- gebdi Dental Products GmbH (10031212)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 4, 2010
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Denture, Plastic, Teeth | ELM | 2 | Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 24, 2009 | K092231 | GEBDI TRIBOS 501 | ELM | Substantially Equivalent | Gebdi Dental-Products GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Denture, Plastic, Teeth
- All makers of Material, Impression Tray, Resin
- All makers of Wax, Dental, Intraoral
Updated November 24, 2009. 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.