Manufacturer registered with FDA
Dimeda Instrumente GmbH
TUTTLINGEN, Germany. Lists 35 dental device types with FDA across 1 registered establishment.
- Device types listed
- 35
- Brands and models
- 26
- 510(k) clearances
- 0as applicant
- Markets registered in
- 96,568 registrations outside the US
- Establishments
- 1Germany
Registered in 9 markets
Where regulators' registries name Dimeda Instrumente 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 | Dimeda Instrumente GmbH | 35 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | DIMEDA INSTRUMENTE GMBH | 6,187 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Dimeda Instrumente GmbH | 305 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DIMEDA Instrumente GmbHDimeda Instrumente GmbH | 49 | 2003–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DIMEDA INSTRUMENTE GmbHDIMEDA INSTRUMENTE GMBH | 18 | 2014–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DIMEDA INSTRUMENTE GMBH | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dimeda Instrumente GmbH | 3 | 2004–2013 | Pure Global AI |
| Israel | AMAR | Manufacturer | DIMEDA Instrumente GmbH | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Dimeda Instrumente GmbH | 1 | 2011–2011 | 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 Dimeda Instrumente GmbH currently lists, by FDA device type, with the brand and model names on the listing.
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 |
|---|---|---|
| DIMEDA INSTRUMENTE GMBHFDA reg. 9611283 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010631). 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.