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

    Irritrol, EDS Combo-Rinse

    K Number: K150020 · Decision Feb 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    Irritrol, EDS Combo-Rinse
    K Number
    K150020
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Essential Dental Systesm, Inc.
    Date Received
    January 6, 2015
    Decision Date
    February 25, 2015
    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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