BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    ENDO TWINN

    K Number: K042870 · Decision Jan 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    ENDO TWINN
    K Number
    K042870
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endo Twinn B.V.
    Date Received
    October 18, 2004
    Decision Date
    January 11, 2005
    Product Code
    EKM
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    EKM Gutta-Percha

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