Dental Device Guide
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Manufacturer registered with FDA

Etol Gesundheitspflege-und Pharmaprodukte GmbH

Oberkirch, Germany. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10044316Contract manufacturer
Device types listed
1
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
57 registrations outside the US
Establishments
1Germany

Registered in 5 markets

Where regulators' registries name Etol Gesundheitspflege-und Pharmaprodukte GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 2 registrationsSouth Korea: 2 registrationsTaiwan: 2 registrationsAustralia: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerEtol Gesundheitspflege-und Pharmaprodukte GmbH1 device types—Below
European UnionEUDAMEDManufactureretol Gesundheitspflege- und Pharmaprodukte GmbH2—Pure Global AI
South KoreaMFDSManufactureretol Gesundheitspflege - und Pharmaprodukte GmbH22016–2016Pure Global AI
TaiwanTFDAManufacturerETOL GESUNDHEITSPFLEGE UND PHARMAPRODUKTE GMBHETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH22019–2020Pure Global AI
AustraliaTGAManufactureretol Gesundheitspflege- und Pharmaprodukte GmbH12026–2026Pure 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 Etol Gesundheitspflege-und Pharmaprodukte GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1Denture cleansers & adhesivesMaker—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
ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBHFDA reg. 3003341442Oberkirch Baden-Wurttemberg, GermanyContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10044316). 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.