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510(k) Data Aggregation

    K Number
    K230532
    Device Name
    RADx Intraoral Appliance for Snoring and Sleep Apnea
    Manufacturer
    Achaemenid LLC
    Date Cleared
    2023-07-12

    (135 days)

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

    Achaemenid LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
    Device Description
    The RADx White Night and RADx White Night-p Intraoral Appliance for Snoring and Mild to Moderate Sleep Apnea are removable intraoral devices used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated adjustable rods that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription device customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the user and / or the dentist in increments of 0.5 mm. The custom oral appliance is checked for proper and comfortable fit as well as the appropriate initial progressive arm attachment. The dentist will provide the patient with subsequent progressive arms from 1.0 mm up to 5.0mm in 0.5mm increments. There are 9 different arms each identified with a number for each side of the jaw. The arms are also identified as either "L" for left or "R" for right. Variants / Configurations There are two variants of the device. The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms. The RADx White Night-p was designed with the upper housing and arm as one piece. In this version, the fixed upper tray-arm combination are the progressive parts of the entire apparatus.
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