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510(k) Data Aggregation
K Number
K230532Device 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
872.5570Why 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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