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

    PacEndo EDTA

    K Number: K153528 · Decision Feb 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    40
    Applicant Total
    9
    Review Days
    54

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    Basic Information

    Device Name
    PacEndo EDTA
    K Number
    K153528
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pac-Dent International, Inc.
    Date Received
    December 9, 2015
    Decision Date
    February 1, 2016
    Product Code
    KJJ
    Advisory Committee
    Unknown
    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
    KJJ Cleanser, Root Canal

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