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510(k) Data Aggregation

    K Number
    K222872
    Device Name
    DNA Appliance
    Manufacturer
    Vivos Therapeutics, Inc.
    Date Cleared
    2022-12-30

    (99 days)

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

    Vivos Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DNA Appliance is intended to reduce snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
    Device Description
    The DNA appliance is an intraoral device to reduce snoring, and/or mild to moderate sleep apnea in adults 18 years of age and older. It consists of either an upper tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient. The device is identical to the already-marketed mRNA appliance except the top and bottom trays do not interlock to advance the jaw.
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    K Number
    K210203
    Device Name
    mmRNA appliance
    Manufacturer
    Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I)
    Date Cleared
    2021-08-19

    (205 days)

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

    Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To reduce nighttime snoring and mild to moderate sleep apnea in adults.
    Device Description
    The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient. The device is identical to the already-marketed mRNA appliance except the top and bottom trays interlock using the Herbst telescoping hinge instead of the mRNA flange. It is used in the predicate SomnoMed® device as well as many other devices in the market, e.g. Oasys Sleep (K181571) reference and Oasys Oral/Nasal Airway system (K030440). The mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device.
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