Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004086252

FEI Number

3004086252

Entity Name

MERZ DENTAL GMBH

City/State/Country

LUETJENBURG Schleswig-Holstein, DE

Establishment Address

Kieferweg 1, LUETJENBURG Schleswig-Holstein D-24321, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MERZ DENTAL GMBH (Owner Number: 9055243)

Owner / Operator Contact Address

Kieferweg 1, --, LUETJENBURG, DE-NOTA D-24321, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Promolux HI PremEco Line Prothetic Color System Weropress Promolux artBloc Temp Ceramill Splintec M-PM Disc (Clear) M-Print splint M-Print splint flex M-PM crystal artegral, Polystar Selection M-PM Disc (Pink) PEEK Biosolution M-Print Tray M-Print Surgical guide M-PRINT Surgical guide HT M-Print TryIn

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2014-10-31
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-12-16
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2014-07-23
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2007-12-05
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2014-10-31
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2014-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-11-14
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2022-02-11

Official Correspondent

CLAUDIA BOBROWSKI

US Agent Details

Richard Hunter Business: Washington Regulatory Consultants, LLC Email: rhunterwrc@gmail.com Phone: (505) 4004992

Related Public Records

Same Entity

MERZ DENTAL 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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004086252. Last updated year: 2026. Please use registration number 3004086252 when referencing this establishment in official correspondence.