BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MERZ DENTAL GMBH

    Reg #: 3004086252 · FEI: 3004086252 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    MERZ DENTAL GMBH
    Registration Number
    3004086252
    FEI Number
    3004086252
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kieferweg 1
    City
    LUETJENBURG Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K130076

    Owner / Operator

    Firm Name
    MERZ DENTAL GMBH
    Operator Number
    9055243
    Address
    Kieferweg 1, --
    City
    LUETJENBURG
    State
    DE-NOTA
    Postal Code
    D-24321
    Country
    DE
    Correspondent
    CLAUDIA - BOBROWSKI

    US Agent

    Business Name
    Washington Regulatory Consultants, LLC
    Contact Name
    Richard Hunter
    Address
    5616 Mariola Pl Ne
    City
    Albuquerque
    State
    NM
    ZIP
    87111
    Country
    US
    Email
    [email protected]
    Phone
    505 4004992

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG
    Mouthguard, Prescription MQC
    Denture, Plastic, Teeth ELM
    Material, Tooth Shade, Resin EBF
    Material, Impression Tray, Resin EBH
    Wax, Dental, Intraoral EGD
    Denture Preformed (Partially Prefabricated Denture) EKO

    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 artegral HD PremEco Line set-up wax M-PM Disc (tooth-colored) Coritec PMMA Disc Ceramill Temp Merz Dental PMMA Disc BD Key PMMA BD Load BD Creator BD Key Connect BD Key (Upper & Lower Key) BD Key Plane & Fin Baltic Denture System BD Creator plus BD Key Lock

    Establishment Types

    Manufacture Medical Device