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The DNA Appliance is intended to reduce nighttime snoring and to treat moderate and severe obstructive sleep apnea in children, 6- 17 years of age who are diagnosed with snoring and/or moderate or severe obstructive sleep apnea and need orthodontic treatment.

The DNA appliance is an intraoral device that consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.

The C.A.R.E. Appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. Appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.

The C.A.R.E. appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed. They consist of an upper tray and a lower tray and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient. The DNA appliance does not connect the upper and lower trays, while the mRNA and mmRNA appliances connect the trays with a flange and hinge respectively. The devices are identical to the already-marketed predicates of the same name.

The DNA Appliance is intended to reduce snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

The DNA appliance is an intraoral device to reduce snoring, and/or mild to moderate sleep apnea in adults 18 years of age and older. It consists of either an upper tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient. The device is identical to the already-marketed mRNA appliance except the top and bottom trays do not interlock to advance the jaw.

To reduce nighttime snoring and mild to moderate sleep apnea in adults.

The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient. The device is identical to the already-marketed mRNA appliance except the top and bottom trays interlock using the Herbst telescoping hinge instead of the mRNA flange. It is used in the predicate SomnoMed® device as well as many other devices in the market, e.g. Oasys Sleep (K181571) reference and Oasys Oral/Nasal Airway system (K030440). The mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device.