Manufacturer registered with FDA

Eve Ernst Vetter GmbH

Keltern, Germany. Lists 5 dental device types with FDA across 2 registered establishments.

FDA owner/operator9041174Contract manufacturerManufacturerRepacker / relabeler
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.

All markets
United States: 5 device types listedColombia: 48 registrationsSaudi Arabia: 32 registrationsSouth Korea: 29 registrationsBrazil: 24 registrationsAustralia: 10 registrationsTaiwan: 7 registrationsIsrael: 4 registrationsPeru: 3 registrationsEuropean Union: 2 registrationsUnited Kingdom: 2 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerEve Ernst Vetter GmbH5 device types—Below
ColombiaINVIMAManufacturerEVE ERNST VETTER GMBH48—Pure Global AI
Saudi ArabiaSFDAManufacturerEVE Ernst Vetter GmbH32—Pure Global AI
South KoreaMFDSManufacturerEVE Ernst Vetter GmbHEVE Ernst Vetter GMBH291998–2026Pure Global AI
BrazilANVISAManufacturerEVE ERNST VETTER GMBH242007–2026Pure Global AI
AustraliaTGAManufacturerEve Ernst Vetter GmbH102004–2026Pure Global AI
TaiwanTFDAManufacturerEVE Ernst Vetter GmbHEVE ERNST VETTER GMBH72010–2022Pure Global AI
IsraelAMARManufacturerEVE Ernst Vetter GmbHEve Ernst Vetter GmbH4—Pure Global AI
PeruDIGEMIDManufacturerEVE ERNST VETTER GmbHEVE ERNST VETTER GMBH32024–2025Pure Global AI
European UnionEUDAMEDManufacturerEVE Ernst Vetter GmbH2—Pure Global AI
United KingdomMHRAManufacturerEVE Ernst Vetter GmbH2—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 typeCategoryRoleBrands and modelsListed since
Abrasive PointEHL · Class 1Polishing & prophylaxisMaker—2000
Polishing Agent WheelEJQ · Class 1Polishing & prophylaxisMaker
EVE
2017
Abrasive DiskEHJ · Class 1Polishing & prophylaxisMaker—2016
Polishing Agent StripEHM · Class 1Polishing & prophylaxisMaker—2016
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisMaker—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

EstablishmentLocationWhat it does
D & D POLITEC SRLFDA reg. 3015189687Caransebes Caras-Severin, RomaniaContract manufacturer
EVE ERNST VETTER GMBHFDA reg. 3002613208Keltern Baden-Wurttemberg, GermanyContract 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.