Manufacturer registered with FDA
PRO-MED Instrumente GmbH
Tuttlingen, Germany. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 389 registrations outside the US
- Establishments
- 1Germany
Registered in 3 markets
Where regulators' registries name PRO-MED 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 | PRO-MED Instrumente GmbH | 3 device types | — | Below |
| Taiwan | TFDA | Manufacturer | PRO-MED INSTRUMENTE GMBH | 51 | 2005–2006 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PRO-MED INSTRUMENTE GmbHPRO - MED INSTRUMENTE GmbH · PRO-MED INSTRUMENTE GMBH | 38 | 2008–2025 | 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 PRO-MED Instrumente 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 |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | — | 1995 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | — | 1995 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | — | 1995 |
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 |
|---|---|---|
| PRO-MED INSTRUMENTE GMBHFDA reg. 8010733 | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010733). 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.