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The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor is intended to reduce snoring and mild to moderate obstructive sleep apnea (OSA) and monitor patient usage in an adult population.

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are intraoral devices used for treating and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. Additionally nasal dilator buttons are attached to the upper appliance, that when engaged stretch the nasio-label tissue in order to increase space in the nasal airway passage thus reducing tissue obstructions that aid in reducing snoring and OSA. The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint and by the base material engaging the undercuts of the teeth. The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. Additionally, the devices include the Dentitrac ® patient monitoring system as characterized under the Braebon Dentitrac MAF 2557 to help monitor patient compliance to prescribed usage.

OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.

The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of: - Lower tray fitted over the lower teeth. - Upper shield fitting in front of upper anterior teeth. - Upper molded splint fitted over upper teeth. - Connecting mechanism joining upper shield and lower tray. - Extensions off shield which act as nasal dilators.