BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono

    K Number: K171562 · Decision Apr 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    6
    Review Days
    318

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    Basic Information

    Device Name
    Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
    K Number
    K171562
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dreve Dentamid GmbH
    Date Received
    May 30, 2017
    Decision Date
    April 13, 2018
    Product Code
    ELW
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ELW Material, Impression

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