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

    DENTEK EASY BRUSH WITH FLUORIDE

    K Number: K130186 · Decision Jul 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    574
    Same Product Code
    48
    Applicant Total
    8
    Review Days
    171

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    Basic Information

    Device Name
    DENTEK EASY BRUSH WITH FLUORIDE
    K Number
    K130186
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Den Tek Oral Care, Inc.
    Date Received
    January 25, 2013
    Decision Date
    July 15, 2013
    Product Code
    EFW
    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
    EFW Toothbrush, Manual

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