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- 1. A device to be used for the treatment of sleep bruxism and - 2. As an aid in the treatment of associated tension/migraine type headaches in adults.

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This appliance is designed to treat primary snoring and mild to moderate obstructive sleep apnea in adults.

The Luco Hybrid OSA Appliance is a two part (upper and lower) mandibular advancement appliance that advances the mandible (and tongue) into a forward position and maintains it there while sleeping. This appliance, as well as all three predicates identified, are made patient specific by a dental lab for each patient. The framework of the Luco Hybrid OSA appliance is constructed of dental alloy (chrome cobalt), similar to a cast partial denture, increasing its strength. The acrylic used for the pads, wings and adjustment blocks is orthodontic methyl methacrylate from Dentaurum. All of the predicate appliances use orthodontic methyl methacrylate from Dentaurum in their design. Orthodontic type ball clasps are placed on the inside (lingual surfaces) of the bicuspids and molars for retention. The SomnoMed MAS and Oravan OSA also use orthodontic ball clasps and wires for retention. There are acrylic pads on both the upper and lower appliances which cover and protect the posterior teeth (similar to all the predicates). There is no acrylic over the upper and lower incisors; instead there is an orthodontic type retainer wire to prevent flaring of the upper and lower incisors and a cast dental alloy custom fit plate behind the lower incisors. The predicate Oravan OSA appliance similarly does not place acrylic in the anterior of upper and lower teeth. The absence of any acrylic over the incisors in the front of the mouth allows freedom to breathe through the mouth as needed or to evacuate the oropharynx in the case of illness or an emergency such as vomiting. The patient can speak and drink water without removing the appliance. The absence of any material in the anterior region also activates and inhibits pharyngeal reflexes which result in the tongue posturing forward. The Luco Hybrid and all three predicates use wings on the lower appliance that extend upward contacting adjustable blocks on the upper appliance. These wings retain the lower jaw in a predetermined position while allowing the patient to open and move laterally with freedom. The adjustment blocks of the upper appliance have adjustment screws that permit fine adjustments (each turn gives ¼ mm advancement, up to 6mm) similar to all of the predicates. The predetermined position is determined by the dentist ordering the appliance; usually as a bite registration taken with a dedicated apparatus such as a George Gauge® (these are readily available from dental supply companies) similar to the predicate appliances. Advancing the mandible prevents blockage of the upper airway permitting normal air exchange, and effectively treating primary snoring and mild to moderate obstructive sleep apnea. The pads are constructed such that the main area of contact is in the forward 25% of the pads with no contact in the molar regions. The pads (both on the upper and lower appliance) have a chrome cobalt mesh inside for increased strength. The wings of the lower appliance as well as the upper adjustment blocks also have chrome cobalt mesh for strength. This mesh is continuous with the main framework of the appliance providing considerable strength.