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Merz Dental GMBH: FDA-registered device maker in LUETJENBURG Schleswig-Holstein, Germany, 8 510(k) clearances

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

Merz Dental GMBH is registered with the FDA (registration 3004086252) in LUETJENBURG Schleswig-Holstein, Germany. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 18, 2017. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3004086252
Address: Kieferweg 1, LUETJENBURG Schleswig-Holstein, Germany, D-24321
Owner or operator: MERZ DENTAL GMBH (9055243)
Roles: Manufacturer
First device listed: December 5, 2007
Registered through: 2027
Brand names listed: BD Creator, BD Creator plus, BD Key (Upper & Lower Key), BD Key Connect, BD Key Lock, BD Key PMMA, BD Key Plane & Fin, BD Load and more

Devices it lists

Device	Product code	Class	Role	Source
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Denture Preformed (Partially Prefabricated Denture)	EKO	2	Manufacturer	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	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
December 18, 2017	K173124	PEEK Biosolution	EBF	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
September 15, 2014	K140758	M-PM-DISC (PINK)	EBI	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
April 11, 2014	K134015	M-PM-DISC	MQC	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
August 22, 2013	K130076	PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS	EBI	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
May 21, 2012	K120404	MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH	ELM	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
May 2, 2008	K080556	ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES	EBG	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
August 21, 2007	K071548	WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED	EBG	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov
May 7, 2003	K030588	ARTEGRAL AND POLYSTAR SELECTION	ELM	Substantially Equivalent	Merz Dental GmbH	accessdata.fda.gov

Compare with other makers

Updated December 18, 2017. 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.