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510(k) Data Aggregation

    K Number
    K130067
    Device Name
    MRNA APPLIANCE
    Manufacturer
    BIOMODELING SOLUTIONS, LLS
    Date Cleared
    2014-05-08

    (483 days)

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

    BIOMODELING SOLUTIONS, LLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the treatment of snoring and mild to moderate obstructive sleep apnea in adults.
    Device Description
    The mRNA appliance is an intraoral device used for treating and mild to moderate sleep apnea, functioning as a mandibular repositioner and acting to increase the patient's pharyngeal space to improve the ability to exchange air. It consists of two customized trays that fit over the upper and lower teeth. An adjustment mechanism enables the device to be customized for each patient. The mRNA appliance is a customized oral device featuring both lower (optional) and upper interlocking trays. These trays prevent the collapsing of the tissues in the back of the throat and preserves the airway. The mRNA appliance consists of upper and lower interlocking, customized trays. The mRNA appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The mRNA appliance allows for interlocking of the upper and lower trays; the mandibular position may be adjusted antero-posteriorly (AP), transversely (TV), as well as permitting adjustments of the vertical dimension of occlusion (VDO). The interlocking of the upper and lower trays to permit adjustments in the vertical dimension is the primary unique feature of this design.
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