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The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The airVata™ sleep appliance is a mandibular advancement device. It holds the mandible in a protrusive position as determined by a trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin. Connectors, made of a biocompatible synthetic polymer with injection molding technology attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 1.0 mm increments by using different lower trays supplied with the device. The connectors are attached after the upper and lower splints (trays) are manufactured. The Subject device is a single patient, non-sterile, prescription-only device. It is to be used only by the patient for whom it is custom designed. It is to be worn during sleep and may be removed by the patient at any time.