BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700

    K Number: K042828 · Decision Dec 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
    K Number
    K042828
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Young O/S, LLC
    Date Received
    October 12, 2004
    Decision Date
    December 1, 2004
    Product Code
    EKR
    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
    EKR Plugger, Root Canal, Endodontic

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