Manufacturer registered with FDA
Eve Ernst Vetter GmbH
Keltern, Germany. Lists 5 dental device types with FDA across 2 registered establishments.
- Device types listed
- 5
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 11161 registrations outside the US
- Establishments
- 2Germany, Romania
Registered in 11 markets
Where regulators' registries name Eve Ernst Vetter 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 | Eve Ernst Vetter GmbH | 5 device types | — | Below |
| Colombia | INVIMA | Manufacturer | EVE ERNST VETTER GMBH | 48 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | EVE Ernst Vetter GmbH | 32 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | EVE Ernst Vetter GmbHEVE Ernst Vetter GMBH | 29 | 1998–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | EVE ERNST VETTER GMBH | 24 | 2007–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Eve Ernst Vetter GmbH | 10 | 2004–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | EVE Ernst Vetter GmbHEVE ERNST VETTER GMBH | 7 | 2010–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | EVE Ernst Vetter GmbHEve Ernst Vetter GmbH | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | EVE ERNST VETTER GmbHEVE ERNST VETTER GMBH | 3 | 2024–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | EVE Ernst Vetter GmbH | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | EVE Ernst Vetter GmbH | 2 | — | 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 Eve Ernst Vetter 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 |
|---|---|---|---|---|
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | — | 2000 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | EVE | 2017 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | — | 2016 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | — | 2016 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | 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 |
|---|---|---|
| D & D POLITEC SRLFDA reg. 3015189687 | Caransebes Caras-Severin, Romania | Contract manufacturer |
| EVE ERNST VETTER GMBHFDA reg. 3002613208 | Keltern Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
D & D Politec S.r.l.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9041174). 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.