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The TheraSom-CAST is used to reduce or alleviate the occurrence of snoring and/or for the treatment of mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.

The TheraSom-CASTTM anti-snoring device is a removable, adjustable intraoral device intended for the treatment of snoring and mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years or older. The device functions as a mandibular repositioner, which acts to improve the patient's ability to breathe without obstruction of the pharyngeal airway. The TheraSom-CAST is customized by molding to conform to the patient's dentition. Like the predicate devices, this device is comprised of an upper and lower component, each fitted over the corresponding dentition and coupled together by a locking mechanism. The locking mechanism of the TheraSom-CAST is formed by stainless steel tension springs connected to the upper and lower components externally on either side of the device. The springs may vary in lengths and may be moved to adjust the relative positions of the upper and lower components so as to set the distance of the mandibular advancement. While the device includes no plastic parts (the upper and lower components are made from dental cast alloy and the springs are formed of stainless steel); this difference in materials and the construction by customized dental cast molding do not introduce any new safety issues.