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510(k) Data Aggregation

    K Number
    K162543
    Device Name
    Reverse Pull Adjustable Facemask
    Manufacturer
    SAWBROS INDUSTRIES PVT.LTD.
    Date Cleared
    2017-08-28

    (350 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAWBROS INDUSTRIES PVT.LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use as a treatment option for Class III malocclusion.
    Device Description
    The Reverse Pull Adjustable Facemask is an extra oral device placed on the face of a patient. The subject device is provided assembled; packaged in a plastic heat sealed bag placed in a nylon pouch, to safeguard the integrity of the packaging. The device is provided non(sterile. No prior skin preparation is required to use the device. The skin contacting surfaces may require light cleaning with water between uses, depending on the patient's personal hygiene. The subject device consists of a vertical main frame, made of 304(grade stainless steel, having adjustable supports for the patient's forehead and chin. The two supports are lined with Ethylene( Vinyl Acetate (EVA) plastic foam for patient comfort. Moreover, the forehead support has two vents to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene. An elastic capstan crossbar made of 304 grade stainless steel, with an allen screw is present on the vertical main frame between the forehead and chin support. The crossbar is utilized by the Orthodontic practitioner as a means of anchorage support for attaching elastics to intraoral appliances. Elastics or the intraoral appliances are not provided with this device.
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