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510(k) Data Aggregation

    K Number
    K243752
    Manufacturer
    Date Cleared
    2025-09-17

    (286 days)

    Product Code
    Regulation Number
    872.5570
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K222127, K143244

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults

    Device Description

    The Double Tube Herbst appliance consists of upper and lower base appliances connected on each side by a telescopic apparatus that advances the mandible. Each telescopic apparatus is loosely but securely attached to wire loops formed at the ends of retentive anchors embedded in the acrylic on the outer (buccal) surfaces of the upper and lower base appliances. A telescopic apparatus consists of a double tube telescopic assembly that is attached to the back end of the upper wire loop; and a rod that is attached to the front end of the lower wire loop. The double tube telescopic assembly consists of a short internally threaded tube welded in parallel onto the back of a long straight tube in which the rod slides. The short internally threaded tube is adjustably attached to the back end of the upper wire loop by engaging the externally threaded lower end of a connector, the upper end of which ends in a helix that is twisted around the upper wire loop. The rod that slides in and out of the long tube is loosely but securely attached to the wire loop on the front end of the lower retentive anchor. The lengths of the telescopic assemblies can be adjusted in 1/2 mm increments along a range of 15 mm by disengaging the telescopic components, rotating the double tube assembly around the connecting arm, and sliding the rod back into the long tube to lock in the adjustment.
    The Double Tube Herbst appliance is worn while sleeping to keep the mandible in a forward position prescribed by the treating dentist to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The customized appliance is inserted and removed by the patients every night, and it is adjusted by the prescribing dentist.

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