Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004971271

FEI Number

3004971271

Entity Name

EISENBACHER DENTALWAREN ED GMBH

City/State/Country

WOERTH Bavaria, DE

Establishment Address

DR.-KONRAD-WIEGAND-STRASSE 9, WOERTH Bavaria 63939, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EISENBACHER DENTALWAREN ED GMBH (Owner Number: 9068197)

Owner / Operator Contact Address

DR.-KONRAD-WIEGAND-STRASSE 9, --, WOERTH, DE-NOTA 63939, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kera starSplint Bio Kera S-Powder KERA-DISC, Ceramill CoCr Kera N Kera Soft-Disc Kera C Robur 400 Kera NH Keragen Dentium Kera® Ti 5-Disc, Ceramill Titan Main Metall Tener IT Kera® Ti 2-Disc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2023-06-23
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2004-11-12

Official Correspondent

CLAUDIA BOLZ-WEIGAND

US Agent Details

Jane Campbell Business: J & D Campbell Associates Inc. Email: jdcainc.sc@gmail.com Phone: (843) 3143670

Related Public Records

Same Entity

EISENBACHER DENTALWAREN ED GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004971271. Last updated year: 2026. Please use registration number 3004971271 when referencing this establishment in official correspondence.