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510(k) Data Aggregation

    K Number
    K251628
    Device Name
    Mandibular Advancement Device L07
    Manufacturer
    DCSTAR INC
    Date Cleared
    2025-10-22

    (147 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K170825
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mandibular Advancement Device is designed to advance the user's lower jaw and maintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.

    Device Description

    The L07 Mandibular Advancement Device is an intraoral device that is used to maintain the lower jaw in a forward position to increase pharyngeal space so as to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.

    The L07 Mandibular Advancement Device include three types: Type A, Type B, Type C. Each type includes one upper tray and one lower tray. The upper tray of these three types are the same, while they are only different in lower tray. By combining upper tray with different lower tray, the device can be used for advancing lower jaw from 0mm to 6mm.

    AI/ML Overview

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