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510(k) Data Aggregation

    K Number
    K190236
    Device Name
    O2Vent Optima
    Manufacturer
    Oventus Manufacturing PTY LTD
    Date Cleared
    2019-08-29

    (204 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oventus Manufacturing PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O2Vent Optima is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
    Device Description
    The O₂Vent Optima is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O₂Vent Optima consists of the following parts: Upper tray (upper teeth) Lower tray (lower teeth) Connector bands The upper tray is fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance. The upper nylon tray has two side protrusions (lugs) that engage a connector that when attached, extends to the lower tray and attaches to a similar lug stabilizing and advancing the lower jaw. The lower tray, is customized to the bottom teeth, which when attached to the same connector via a side protrusion (lug) preventing the tongue and soft tissues of the throat from collapsing and obstructing the airway. In order to adjust the trays to the specific needs of the user, various length bands (13-21mm) are used to move the lower jaw (i.e. adjust the trays) forward or backward. The shorter the connector band, the further the lower jaw is moved forwards. The O2Vent Optima is delivered fully assembled with the 19mm connector band as the recommended starting titration length for all new users. The upper and lower trays of the O2Vent Optima are made with PA2200 (i.e. Nylon). The straps which connect the upper and lower trays together are made of 100% thermoplastic polyurethane/cured elastomer.
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    K Number
    K171316
    Device Name
    O2Vent W
    Manufacturer
    Oventus Manufacturing Pty Ltd
    Date Cleared
    2017-07-11

    (68 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oventus Manufacturing Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O2Vent W is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
    Device Description
    The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent W is made up of two parts: 1. The Upper Tray fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from medical grade titanium (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression. 2. The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch. The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.
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    K Number
    K161832
    Device Name
    O2VENT T
    Manufacturer
    OVENTUS MANUFACTURING PTY LTD
    Date Cleared
    2016-09-23

    (80 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OVENTUS MANUFACTURING PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O2Vent T is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
    Device Description
    The O2Vent T is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent T is made up of three parts: 1. The Upper Tray fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from medical grade titanium 2. The Lower Tray fitted over the lower teeth, positions the jaw for mandibular advancement. The Upper and Lower Trays have a "landing area" customized to the patient's teeth and made from medical grade polymers. 3. The Upper and Lower Trays are connected together with a connector. A hook mechanism attached to the Upper Tray fits into a socket attached to the Lower Tray and positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. An Adjustment Key for the O2Vent T allows the patient and their Clinician to adjust the protrusion of the lower jaw to the most effective and comfortable position.
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    K Number
    K160234
    Device Name
    OVENT
    Manufacturer
    OVENTUS MANUFACTURING PTY LTD
    Date Cleared
    2016-03-17

    (45 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OVENTUS MANUFACTURING PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OVENT is a removable medical device that is fitted in the patient is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, OSA. The device is indicated for use during sleep to aid in the treatment of these conditions. The OVENT is for prescription use only.
    Device Description
    The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of: • A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth. • A dental polymer material in each tray which is in contact with and retaining in position, the user's top and bottom teeth. • The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user's snoring condition. • A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.
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