BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ERKODENT ERICH KOPP GMBH

    Reg #: 8010662 · FEI: 5513 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ERKODENT ERICH KOPP GMBH
    Registration Number
    8010662
    FEI Number
    5513
    Status
    Active
    Expiry Year
    2026
    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
    Tray, Impression, Preformed EHY

    Proprietary Names

    Erkolign Erkolen Erkoplast PLA Erkoflex Erkodur Playsafe triple Erkoloc-pro ERKOFLEX AND ERKOPLAST

    Establishment Types

    Manufacture Medical Device