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

    EPIEN ROOT CANAL CLEANSER

    K Number: K123538 · Decision Feb 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    EPIEN ROOT CANAL CLEANSER
    K Number
    K123538
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epien Medical, Inc.
    Date Received
    November 16, 2012
    Decision Date
    February 1, 2013
    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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    Other Clearances by Epien Medical, Inc.

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