BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    indigodental GmbH

    Reg #: 3006694515 · FEI: 3006694515 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    indigodental GmbH
    Registration Number
    3006694515
    FEI Number
    3006694515
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fahltskamp 5
    City
    Pinneberg Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K011211

    Owner / Operator

    Firm Name
    indigodental GmbH
    Operator Number
    10023218
    Address
    Fahltskamp 5
    City
    Pinneberg
    State
    Schleswig-Holstein
    Postal Code
    25421
    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

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device