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510(k) Data Aggregation
(91 days)
The Anti Snoring Mouthpiece 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.
The L08 series Anti Snoring Mouthpiece 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.
L08 series Anti Snoring Mouthpiece includes three upper trays (A0, A2, A4) and three lower trays (B0, B1, B2). One upper tray and one lower tray are combined together for use. By randomly combining one upper tray with one lower tray, the device can be used for advancing lower jaw from 0mm to 6mm.
Considering that the size of the oral cavity varies among different groups of people, L08 series Anti Snoring Mouthpiece is designed to be available for two size (L and S).
Even though the dimensions of these sizes of Anti Snoring Mouthpiece are different, by positioning the upper protrusion and the lower protrusion at different locations within the upper tray assembly and the lower tray assembly respectively, advancement distance of 0-6 mm can still be realized.
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