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510(k) Data Aggregation

    K Number
    K150566
    Device Name
    Oniris
    Manufacturer
    SAS Oniris
    Date Cleared
    2016-03-21

    (381 days)

    Product Code
    LRK
    Regulation Number
    872.5570
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    Applicant Name (Manufacturer) :

    SAS Oniris

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oniris device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults.
    Device Description
    The Oniris Mandibular advancement device is an intraoral device for use during up to 8 hours of sleep, and composed of two injection molded thermoplastic trays overmoulded with thermoforming resin and customized to fit over the patient's teeth. The trays are attached and articulated through interconnecting rods to allow for mandibular advancement in relation to the maxilla up to 11 mm of protrusion. Mandibular advancement is the mechanism of action to increase upper airway opening to reduce snoring and mild to moderate sleep apnea. The Oniris device is formed to upper and lower teeth without the need of taking a patient's dental impressions. Oniris device is a "boil-&-bite" device, the trays are customizable. This mandibular advancement device maintains performance for 12 to 24 months depending on its conditions of use and maintenance as well as the patient's salivary composition. Oniris mandibular device is proposed in two sizes to be adapted to different sizes of jaw (size 2 in the same box). The practitioner/dentist has to choose the most comfortable size for the patient.
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