Data / Medical devices / Germany / Hager & Werken GMBH

Hager & Werken GMBH: FDA-registered device maker in DUISBURG,DE-NOTA Hamburg, Germany, 1 510(k) clearance

Name: Hager & Werken GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hager & Werken GMBH is registered with the FDA (registration 3003487388) in DUISBURG,DE-NOTA Hamburg, Germany. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2005. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003487388
Address: Ackerstrasse 1, DUISBURG,DE-NOTA Hamburg, Germany, D-47269
Owner or operator: HAGER & WERKEN GMBH (9050764)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: April 16, 2002
Registered through: 2027
Brand names listed: COMPO BLITZ, COTTON CLIPS II, Happy Morning Toothbrush, MIRA COMPO , COMPO BRUSH, MIRAFLOSS, MIRAJECT ENDO RINSE, MIRAWHITE PRO, OCCLU PRINT and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Repackager or relabeler	accessdata.fda.gov
Dental Hygiene Kit	NXZ	1	Manufacturer	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Floss, Dental	JES	1	Manufacturer	accessdata.fda.gov
Frame, Rubber Dam	EJE	1	Contract manufacturer	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Manufacturer	accessdata.fda.gov
Pick, Massaging	JET	1	Manufacturer	accessdata.fda.gov
Pin, Retentive And Splinting, And Accessory Instruments	EBL	1	Manufacturer	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Manufacturer	accessdata.fda.gov
Teeth, Artificial, Posterior With Metal Insert	ELJ	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Complaint file establishment	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 27, 2005	K050658	RESO-PAC PERIODONTAL DRESSING	EMA	Substantially Equivalent	Hager Worldwide, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 27, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.