Manufacturer registered with FDA
gebdi Dental Products GmbH
Engen, Germany. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 12009–2009
- Markets registered in
- 6765 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name gebdi Dental Products GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | gebdi Dental Products GmbH | 1 clearances | 2009–2009 | Below |
| European Union | EUDAMED | Manufacturer | gebdi DENTAL-PRODUCTS GmbH | 760 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GEBDI DENTAL-PRODUCTS GMBH | 2 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | GEBDI DENTAL PRODUCTS GMBH | 1 | 2016–2016 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Gebdi Dental Products GmbH. | 1 | 2009–2009 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | gebdi DENTAL-PRODUCTS GmbH | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What gebdi Dental Products GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | — | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | — | 2011 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | — | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GEBDI DENTAL PRODUCTS GMBHFDA reg. 3002727993 | Engen Baden-Wurttemberg, Germany | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031212). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.