BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ROEKO GuttaFlow 2

    Reg #: 8010629 · FEI: 3001180585 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    COLTENE/WHALEDENT GMBH & CO. KG
    Registration Number
    8010629
    FEI Number
    3001180585
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RAIFFEISENSTRASSE 30
    City
    LANGENAU Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K032662

    Owner / Operator

    Firm Name
    COLTENE Holding AG
    Operator Number
    9047609
    Address
    FELDWIESENSTRASSE 20, --
    City
    ALTSTAETTEN
    State
    Sankt Gallen
    Postal Code
    9450
    Country
    CH

    US Agent

    Business Name
    COLTENE/WHALEDENT INC.
    Contact Name
    Tricia Cregger
    Address
    235 Ascot Parkway
    City
    Cuyahoga Falls
    State
    OH
    ZIP
    44223
    Country
    US
    Email
    [email protected]
    Phone
    330 9168904

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF
    Gutta-Percha EKM

    Proprietary Names

    ROEKO GuttaFlow 2 ROEKO GuttaFlow

    Establishment Types

    Manufacture Medical Device