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510(k) Data Aggregation

    K Number
    K252976

    Validate with FDA (Live)

    Device Name
    Park Dental Nylon MAD
    Manufacturer
    Park Dental Research Corp.
    Date Cleared
    2025-12-18

    (92 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Age Range
    18 - 150
    Reference & Predicate Devices
    K240427,K171576
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K240427

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

    The Park Dental Nylon MAD is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

    Device Description

    The Park Dental Nylon Mandibular Advancement Device (MAD) is a custom-made, removable oral appliance consisting of two intraoral trays connected by an adjustable interlocking rigid rod. It is intended for use in patients diagnosed with Obstructive Sleep Apnea (OSA) and functions by advancing the lower jaw (mandible) during sleep to increase the pharyngeal airway space. This advancement reduces airway obstruction, minimizes snoring, and promotes improved sleep quality and reduced jaw tension.

    AI/ML Overview

    N/A

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