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

    Oral-B iO Test Drive Power Brush Trial Program Kit

    K Number: K200881 · Decision Aug 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    343
    Registration Numbers
    344
    Same Product Code
    53
    Applicant Total
    5
    Review Days
    147

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    Basic Information

    Device Name
    Oral-B iO Test Drive Power Brush Trial Program Kit
    K Number
    K200881
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6865
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Procter & Gamble Company
    Date Received
    April 2, 2020
    Decision Date
    August 27, 2020
    Product Code
    JEQ
    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
    JEQ Toothbrush, Powered

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