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510(k) Data Aggregation

    K Number
    K143623
    Device Name
    Narval Brux
    Manufacturer
    RESMED SAS
    Date Cleared
    2015-08-13

    (234 days)

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

    RESMED SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.
    Device Description
    The Narval Brux is a removable intraoral device used for protecting teeth and restorations aqainst the forces of bruxism. It consists of patient-specific splints that fit separately over the upper or lower teeth. The design of the splints is dependent on the patient needs. The device functions as a protective barrier for teeth and restorations by creating physical separation between posterior occlusal surfaces and/or anterior incisal edges which will prevent tooth damage caused by grinding, bruxing and may help alleviate jaw and muscle pain. The device is customized for each patient based on the clinician prescription.
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    K Number
    K113201
    Device Name
    NARVAL CC
    Manufacturer
    RESMED SAS
    Date Cleared
    2011-12-01

    (31 days)

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

    RESMED SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Narval CC™ is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The Narval CC is a removable intraoral device used for treating snoring and sleep apnea. It consist of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving his/her ability to exchange air and reducing the tendency to snore. The device is custom made for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting.
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