Manufacturer registered with FDA
Renfert GmbH
Hilzingen, Germany. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 989 registrations outside the US
- Establishments
- 1Germany
Registered in 9 markets
Where regulators' registries name Renfert 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 | Renfert GmbH | 3 device types | — | Below |
| South Korea | MFDS | Manufacturer | Renfert GmbHRenfert GmbH. · RENFERT GmbH | 53 | 1998–2012 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RENFERT GMBH | 11 | 2007–2023 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Renfert GmbH | 6 | 2022–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Renfert GmbH | 5 | 2007–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Renfert GmbH | 5 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Renfert GmbH | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Renfert GmbH | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | RENFERT GMBH. | 2 | 2023–2024 | 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 Renfert 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 |
|---|---|---|---|---|
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | DUOMIXDUOMIX IIDynamix Speed 2PROMIX oneSYMPRESSSYMPRESS II | 2007 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Sympro | 2021 |
| Prescription Denture CleanserNUX · Class 1 | — | Maker | help:ex discolor fhelp:ex plaque fhelp:ex plaque ptemp:ex | 2017 |
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 |
|---|---|---|
| RENFERT GMBHFDA reg. 3001065024 | HILZINGEN Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052056). 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.