BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    indigodental GmbH

    Reg #: 3006694515 · FEI: 3006694515 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    indigodental GmbH
    Registration Number
    3006694515
    FEI Number
    3006694515
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Fahltskamp 5
    City
    Pinneberg Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K982692

    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
    Syringe, Restorative And Impression Material EID
    Cement, Dental EMA
    Sealant, Pit And Fissure, And Conditioner EBC
    Crown And Bridge, Temporary, Resin EBG
    Coating, Filling Material, Resin EBD
    Material, Impression ELW
    Cord, Retraction MVL
    Material, Impression Tray, Resin EBH
    Applicator, Resin KXR
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Agent, Tooth Bonding, Resin KLE
    Handle, Instrument, Dental EJB

    Proprietary Names

    QuikGlaze QuikGlaze XL QuikGlaze Temp White PROVISA CEM TEMP CEM CLR SYR

    Establishment Types

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