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SmartGuard Anti-Snore Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring.

The SmartGuard® Anti-Snore Device is an intra-oral device composed of two independent injection molded thermoplastic (Polycarbonate) trays, over molded with thermoforming resin (EVA). One tray is for the maxillary arch, labeled "Upper", and one tray is fitted to the mandibular arch, labeled "Lower". Both trays are custom fitted by the end user via "Boiland-Bite" process at home. A molding aid is included in the packaging to assist the user in the customization of the trays. The molding aid is constructed with the same Polycarbonate material as the upper and lower trays, as well as the Advancement Bars. Once the trays are molded to the user's teeth, the trays are connected via the insertion of Advancement Bars, which are available in 6 sizes, varying in length by 1mm. The Advancement Bars interlock with the mandibular and maxillary trays and holds the mandible forward which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. Because the trays are independent, the user can articulate vertically, allowing for greater airflow and comfort. As with all listed predicate devices, SmartGuard® Anti-Snore Device is a Mandibular Advancement Device (MAD) and is easily adjusted by the user to allow for up to 6mm of protrusion. The user can interchange the various sizes of Advancement Bars to find the size that comfortably advances the mandible and reduces snoring.