BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PEEK Biosolution

    Reg #: 3004086252 · FEI: 3004086252 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MERZ DENTAL GMBH
    Registration Number
    3004086252
    FEI Number
    3004086252
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kieferweg 1
    City
    LUETJENBURG Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K173124

    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
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    PEEK Biosolution

    Establishment Types

    Manufacture Medical Device