Dental Device Guide
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Manufacturer registered with FDA

Eisenbacher Dentalwaren ED GmbH

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

FDA owner/operator9068197Manufacturer
Device types listed
1
Brands and models
13
510(k) clearances
0as applicant
Markets registered in
924 registrations outside the US
Establishments
1Germany

Registered in 9 markets

Where regulators' registries name Eisenbacher Dentalwaren ED GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedCanada: 7 registrationsAustralia: 3 registrationsBrazil: 3 registrationsEuropean Union: 3 registrationsSaudi Arabia: 3 registrationsSerbia: 2 registrationsUnited Kingdom: 2 registrationsChina: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerEisenbacher Dentalwaren ED GmbH1 device types—Below
CanadaHealth CanadaRegistration holderEISENBACHER DENTALWAREN ED GMBH72014–2025Pure Global AI
AustraliaTGAManufacturerEisenbacher Dentalwaren ED GmbH32024–2026Pure Global AI
BrazilANVISAManufacturerEisenbacher Dentalwaren ED GmbH32015–2022Pure Global AI
European UnionEUDAMEDManufacturerEisenbacher Dentalwaren ED GmbH3—Pure Global AI
Saudi ArabiaSFDAManufacturerEisenbacher Dentalwaren ED GmbH3—Pure Global AI
SerbiaALIMSManufacturerEisenbacher Dentalwaren ED GmbH22024–2024Pure Global AI
United KingdomMHRAManufacturerEisenbacher Dentalwaren ED GmbH2—Pure Global AI
ChinaNMPARegistration holder德国埃森巴亨齿科材料制造有限公司Eisenbacher Dentalwaren ED GmbH1—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 Eisenbacher Dentalwaren ED GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Base Metal AlloyEJH · Class 2Dental alloysMaker
DentiumKera CKera NKera NHKera S-PowderKera Soft-DiscKERA-DISC, Ceramill CoCrKera® Ti 2-DiscKera® Ti 5-Disc, Ceramill TitanKeragen
3 more
Main MetallRobur 400Tener IT
2004

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
EISENBACHER DENTALWAREN ED GMBHFDA reg. 3004971271WOERTH Bavaria, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9068197). 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.