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510(k) Data Aggregation

    K Number
    K151933
    Device Name
    BRX PRO Bruxism Guard
    Manufacturer
    12TH MAN TECHNOLOGIES, INC.
    Date Cleared
    2015-12-10

    (149 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    12TH MAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRX PRO™ Bruxism Guard is indicated to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.
    Device Description
    The BRX PRO is a prescription dual arch bruxism guard which protects the teeth and reduces the damage caused by nighttime bruxism and reduces the noise of bruxing or nighttime grinding. The BRX PRO's two arch trays, when filled with impression material, cover approximately eight teeth on each of the upper and lower arches, thereby creating an air-gap between the posterior teeth that prevents tooth contact upon clenching. The two polycarbonate trays are connected in the front with a dual position stainless steel "T-bar" pin in the upper tray and a pair of stainless steel slots in the lower tray that can be set by the prescriber to maintain the BRX PRO trays in a neutral position by selecting one of four positions, while allowing for lateral mandibular movement.
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    K Number
    K142402
    Device Name
    BigEasy Non-Rebreathing Valve
    Manufacturer
    12th Man Technologies, Inc.
    Date Cleared
    2015-03-23

    (208 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    12th Man Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
    Device Description
    The BigEasy™ Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. It provides a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and has a rigid one-way valve that directs exhaled air from the patient away from the rescuer. It also incorporates an oxygen inlet port on the rescuer's side of the valve for the adding of supplemental oxygen without requiring a separate adapter.
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