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510(k) Data Aggregation

    K Number
    K252698

    Validate with FDA (Live)

    Date Cleared
    2025-11-03

    (68 days)

    Product Code
    Regulation Number
    872.5570
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NightGuard Aire Max is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

    Device Description

    The NightGuard Aire Max is a custom made intraoral appliance intended to treat mild to moderate Obstructive Sleep Apnea (OSA) and habitual snoring. The device's primary function is mandibular advancement, which repositions the lower jaw forward during sleep. This forward positioning helps reduce airway obstruction, promoting improved airflow and alleviating symptoms associated with snoring and Obstructive Sleep Apnea (OSA). The device comprises two custom made trays, each featuring two embedded button hooks on each side, and a pair of elastic bands. The hooks are positioned at a distance of 20mm apart from the upper tray hook to the bottom tray hook. These hooks serve as secure attachment points for the elastic bands, which serve to keep the trays in place. The bands are available in four different sizes (20mm, 19mm, 18mm, and 17mm) ensuring a functional, customizable fit for each patient. The upper and lower trays each support a structural element, and the structural elements together maintain an open airway. In particular, the lower tray features an anterior platform with a bump elevation located at a position corresponding to a patient's central incisors. This bump serves as a specific point of contact to maintain an open airflow space, supporting the functionality of the anterior platform. The upper tray includes a flat plane at a position corresponding to the patient's central incisors, which works in conjunction with the bump elevation on the lower tray to facilitate airflow during use. The upper and lower trays are manufactured using one of three FDA-cleared, biocompatible materials: Dental LT Comfort Resin, KeySplint Hard Resin, or KeySplint Soft Resin, each of which is suitable for long-term contact with oral tissues.

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