BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    LuxaCore Z-Dual Smartmix A3

    Reg #: 8044164 · FEI: 3004150030 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
    Registration Number
    8044164
    FEI Number
    3004150030
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ELBGAUSTRASSE 248
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K012307

    Owner / Operator

    Firm Name
    DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
    Operator Number
    9005969
    Address
    ELBGAUSTRASSE 248, --
    City
    HAMBURG
    State
    DE-HH
    Postal Code
    D-22547
    Country
    DE

    US Agent

    Business Name
    Delphi Medical Device Consulting, Inc.
    Contact Name
    Pamela Papineau
    Address
    5 WHITCOMB AVENUE
    City
    Ayer
    State
    MA
    ZIP
    01432
    Country
    US
    Email
    [email protected]
    Phone
    978 7588322

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    LuxaCore Z-Dual Smartmix A3 LuxaCore Z-Dual Smartmix light opaq LuxaCore Z-Dual Smartmix blue LuxaCore Z-Dual AM A3 USA LuxaCore Z-Dual Automix light opaqu LuxaCore Z-Dual Automix A3 LuxaCore Z-Dual AM LO USA LuxaCore Z-Dual AM Blue USA LuxaCore Z-Dual Automix blue LuxaCore Z-Dual SM LO USA LuxaCore Z-Dual SM A3 USA LuxaCore Z-Dual SM blau USA

    Establishment Types

    Manufacture Medical Device