BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VPro5

    K Number: K183018 · Decision Nov 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    366

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    Basic Information

    Device Name
    VPro5
    K Number
    K183018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Propel Orthodontics, LLC
    Date Received
    October 31, 2018
    Decision Date
    November 1, 2019
    Product Code
    OYH
    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
    OYH Orthodontic Vibratory Accessory

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