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SOMNOS ANTI-SNORING MOUTH GUARD is an over-the-counter mouthguard intended for use in adult persons 18 years of age or older as an aid for the reduction of snoring.

SOMNOS ANTI-SNORING MOUTH GUARD is comprised of a mouthguard, a spatula and a storage case. The mouthguard is a self-fitting adjustable Mandibular Advancement Device (MAD) removable intraoral anti-snoring device used to reduce nighttime snoring in adult persons 18 years of age or older. SOMNOS ANTI-SNORING MOUTH GUARD consists of two customized prefabricated single-piece trays that conform to the patient's dentition in the upper and lower jaws. The device functions as a mandibular anterior repositioner, which acts to increase the user's pharyngeal space, resulting in the improvement of the ability to exchange air during sleep. SOMNOS ANTI-SNORING MOUTH GUARD, while in situ. moves the lower jaw forward and helps reduce the likelihood of snoring. It is intended to be worn while sleeping. The supplied spatula is used to separate the SOMNOS ANTI-SNORING MOUTH GUARD. SOMNOS ANTI-SNORING MOUTH GUARD is conformable to wear, and it can be self-fitted by the 'boil and bite' method (when heated the device conforms to person's teeth) and allows slight adjustment of the anterior positioning of the jaw to the person's comfort. SOMNOS ANTI-SNORING MOUTH GUARD is constructed of two (2) preformed and fixed single piece trays composed of Thermoplastic resin Propylene Elastomer (TPE) material, specifically Ethylene-Vinyl-Acetate for the moldable part and Polycarbonate for the rigid part of the device. The spatula and storage case are composed of 100% Polypropylene. The materials in Somnos are commonly used in other 510(k) cleared dental mouth guards for bruxism and antisnoring. The three components (mouthguard, spatula and storage case) are manufactured by injection molding. They are non-flavored and have no color additives. SOMNOS ANTI-SNORING MOUTH GUARD is provided in one model/size, is reusable by a single individual who is at least eighteen (18) years of age and is supplied as non-sterile. Each box of SOMNOS ANTI-SNORING MOUTH GUARD is supplied with the following items: - . (1) Anti-snoring Mouthguard - . (1) Spatula - (1) Storage case ● - (1) Instructions for Use ●

Bright Guard is a mouth guard intended to protect against grinding and clenching. For over-the-counter use.

Bright Guard is comprised of a mouth guard, spatula and storage case. The mouth guard is an over-the-counter, flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individuals who grind their teeth. Bright Guard mouth guard is intended to be worn while sleeping. The mouth guard material is conformable to wear, and it can be self-fit by the 'boil and bite' method (submerging in hot water to make the material malleable to fit on the upper teeth of the oral cavity). Bright Guard mouth guard is constructed of 100% Thermoplastic resin Propylene Elastomer (TPE) material (ethylene-vinyl-acetate) [Elvax]. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. Bright Guard does not contain Bisphenol A (BPA) or phthalates and is free of natural rubber latex. The spatula and storage case are composed of 100% Polypropylene. The materials in Bright Guard are used in various other 510(k) cleared dental mouth guards. The three components (mouth guard, spatula and storage case) are manufactured by injection molding. Bright Guard mouth guard Is provided in one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.