BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Erkoflex

    Reg #: 8010662 · FEI: 5513 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ERKODENT ERICH KOPP GMBH
    Registration Number
    8010662
    FEI Number
    5513
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SIEMENSSTR. 3
    City
    PFALZGRAFENWEILER Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K200125

    Owner / Operator

    Firm Name
    Erkodent Erich Kopp GmbH
    Operator Number
    8010662
    Address
    Siemensstrasse 3
    City
    Pfalzgrafenweiler
    State
    DE-NOTA
    Postal Code
    D-72285
    Country
    DE
    Correspondent
    Hans-Peter Kopp

    US Agent

    Business Name
    AJW Technology Consultants, Inc.
    Contact Name
    Jon Ward
    Address
    11705 Boyette Road, #503
    City
    Riverview
    State
    FL
    ZIP
    33569
    Country
    US
    Email
    [email protected]
    Phone
    813 6452855 ext. 104

    Products

    Device Name Product Code
    Positioner, Tooth, Preformed KMY
    Mouthguard, Prescription MQC

    Proprietary Names

    Erkoflex Erkolen Erkoplast PLA Erkoloc-pro Playsafe triple Erkodur Erkolign

    Establishment Types

    Manufacture Medical Device