Dental Device Guide
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Manufacturer registered with FDA

E Hahnenkratt GmbH

KOENIGSBACH-STEIN, Germany. Lists 8 dental device types with FDA across 1 registered establishment.

FDA owner/operator8010445Contract manufacturerManufacturer
Device types listed
8
Brands and models
9
510(k) clearances
0as applicant
Markets registered in
12115 registrations outside the US
Establishments
1Germany

Registered in 12 markets

Where regulators' registries name E Hahnenkratt GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 8 device types listedTaiwan: 25 registrationsSouth Korea: 17 registrationsBrazil: 16 registrationsAustralia: 13 registrationsSerbia: 13 registrationsIsrael: 9 registrationsUnited Kingdom: 8 registrationsSaudi Arabia: 7 registrationsColombia: 4 registrationsPeru: 2 registrationsEuropean Union: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerE Hahnenkratt GmbH8 device types—Below
TaiwanTFDAManufacturerE. HAHNENKRATT GMBHE. Hahnenkratt GmbH · E.HAHNENKRATT GMBH · +1252005–2023Pure Global AI
South KoreaMFDSManufacturerE.Hahnenkratt GmbHE. HAHNENKRATT GmbH · E. Hahnenkratt GmbH · +1172000–2025Pure Global AI
BrazilANVISAManufacturerE.HAHNENKRATT GMBHE. HAHNENKRATT GMBH162010–2020Pure Global AI
AustraliaTGAManufacturerE Hahnenkratt GmbH132003–2026Pure Global AI
SerbiaALIMSManufacturerE.HAHNENKRATT GmbH132023–2025Pure Global AI
IsraelAMARManufacturerE. Hahnenkratt GmbHE. HAHNENKRATT Gmbh · E.HAHNENKRATT GMBH · +19—Pure Global AI
United KingdomMHRAManufacturerE. Hahnenkratt GmbH8—Pure Global AI
Saudi ArabiaSFDAManufacturerE.HahnenKratt GmbH7—Pure Global AI
ColombiaINVIMARegistration holderE.HAHNENKRATT GMBH4—Pure Global AI
PeruDIGEMIDManufacturerE. HAHNENKRATT GMBHE. HAHNENKRATT GmbH22010–2021Pure Global AI
European UnionEUDAMEDManufacturerE. HAHNENKRATT 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 E Hahnenkratt GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker
HAHNENKRATT DRILLS
2002
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
HAHNENKRATT-MATRIX-BANDS
1979
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
HAHNENKRATT-MOUTH MIRRORS
1979
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker
HAHNENKRATT-HANDLES
1979
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker
HAHNENKRATT Explorers
2016
Root Canal PostELR · Class 1Root canal filling materialsMaker
HAHNENKRATT-JACKET-CROWN-POSTHAHNENKRATT-ROOT-PINS
1979
Matrix RetainerJEP · Class 1Dental hand instrumentsMaker
HAHNENKRATT-MATRIX-RETAINER
1979
Tube Impression and MatrixKCQ · Class 1—Maker
HAHNENKRATT-COPPER BANDS
1979

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
E. HAHNENKRATT GMBHFDA reg. 8010445KOENIGSBACH-STEIN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010445). 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.