HAGER & WERKEN GMBH

FDA Device Registration & Listing · DUISBURG,DE-NOTA Hamburg, DE · Registration 3003487388

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003487388
FEI Number
3003487388
Entity Name
HAGER & WERKEN GMBH
City/State/Country
DUISBURG,DE-NOTA Hamburg, DE
Establishment Address
ACKERSTRASSE 1, DUISBURG,DE-NOTA Hamburg D-47269, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HAGER & WERKEN GMBH (Owner Number: 9050764)
Owner / Operator Contact Address
ACKERSTRASSE 1, --, DUISBURG, DE-NOTA D-47269, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RESO PAC Happy Morning Toothbrush COMPO BLITZ MIRAWHITE PRO MIRA COMPO , COMPO BRUSH MIRAJECT ENDO RINSE MIRAFLOSS COTTON CLIPS II ROTOPROX PIC-BRUSH RFECT PLAST KIT Rubber Dam PREPOMETER SMOCLEAN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EMA Cement, Dental Dental Class 2 872.3275 2006-01-11
EFW Toothbrush, Manual Dental Class 1 872.6855 2023-08-18
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2011-01-19
MAU Eraser, Dental Stain Dental Class 1 872.6855 2006-02-01
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2011-01-19
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2004-07-30
JES Floss, Dental Dental Class 1 872.6390 2006-02-01
EFN Cotton, Roll Dental Class 1 872.6050 2002-04-16
JET Pick, Massaging Dental Class 1 872.6650 2003-04-07
KMT Tray, Fluoride, Disposable Dental Class 1 872.6870 2003-10-03
EJE Frame, Rubber Dam Dental Class 1 872.6300 2012-04-05
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2004-07-30
EJL Bur, Dental Dental Class 1 872.3240 2003-10-03

Official Correspondent

Patrick Rouillard

US Agent Details

Patrick Rouillard Business: HAGER WORLDWIDE, INC. Email: patrick.rouillard@hagerworldwide.com Phone: (828) 6243300

Related Public Records

Same Entity

HAGER & WERKEN 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
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09
K940030 Bisco, Inc. BISCO COMPOSITE 1994-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003487388. Last updated year: 2026. Please use registration number 3003487388 when referencing this establishment in official correspondence.
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