Manufacturer registered with FDA
Eurofins inpac Medizintechnik GmbH
Birkenfeld, Germany. Lists 8 dental device types with FDA across 2 registered establishments.
- Device types listed
- 8
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 26 registrations outside the US
- Establishments
- 2Germany
Registered in 2 markets
Where regulators' registries name Eurofins inpac Medizintechnik 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 | Eurofins inpac Medizintechnik GmbH | 8 device types | — | Below |
| South Korea | MFDS | Manufacturer | Eurofins Inpac Medizintechnik GmbHEurofins inpac Medizintechnik GmbH | 6 | 2019–2026 | 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 Eurofins inpac Medizintechnik 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2013 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | — | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2013 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | — | 2013 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2013 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | — | 2013 |
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 |
|---|---|---|
| EUROFINS INPAC MEDIZINTECHNIK GMBHFDA reg. 3013111980 | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer |
| EUROFINS INPAC MEDIZINTECHNIK GMBHFDA reg. 3007515069 | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043226). 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.