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The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction in mild to moderate obstructive sleep apnea (OSA) and/or snoring. The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction of snoring.

The SleepRight Snore Aid is a customizable adjustable, in 1mm increments up to 6mm total, intraoral mandibular advancement device (MAD). An adjustable stop moves the lower tray, which moves the mandible, to the desired user setting of a position that increases (opens) the pharyngeal space (airway), which aids in minimizing air obstruction and aids in the reduction of snoring during sleep. The SleepRight Snore Aid consists of two independent, customizable moldable, via hot (not boiling) water and bite method, removable, thermoplastic resin injection molded trays, fitted into the user's mouth, that fit separately over the upper (maxillary) and lower (mandibular) dental arches. The upper tray is provided with an adjustable advancement stop mechanism, one on each side of the rear of the upper tray, that provides the incremental 1mm up to 6mm total adjustment. The lower tray is provided with a fin, one on each side of the tray. As the adjustable advancement stop mechanism on each side of the upper tray is incrementally adjusted, the adjustable advancement stop mechanism on each side of the upper tray engages the fin, in a mating position on each side of the lower tray, stabilizing the mandible in a neutral posture or advances the mandible forward until the desired position that opens the airway and aids in a reduction of snoring during sleep is obtained by the user. Because the mandible is attached to the Oropharynx airway tissues (throat), and its posterior movement collapses the airway, stabilizing the mandible in a neutral or advanced forward position opens the airway for improved breathing. Having two independent dental arch trays allows for freedom of movement of the jaw musculature resulting in more user comfort, compliance and efficacy. Necessary Inspiratory and expiratory rapid expulsion of air is also improved.

The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.

The Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring. The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.

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 Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Hushd Pro Avera device series are a set of removable intraoral patient specific device used for treating snoring and mild to moderate obstructive sleep apnea. The device consists of number of custom made maxillary and mandibular splints fit over the upper and lower teeth. when interfaced together, functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the togue and soft tissues of the throat from collapsing into the airway. The Hushd Pro Avera device series are patient-specific devices, consisting of one or more maxillary device(s) and one or more mandibular device(s) that mates together. The sequential devices are CAD/CAM designed and manufactured according to the requested mandibular advancements position prescribed by the dentist or physician to provide a selection of gentle advancements according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing current maxillary or mandibular device and inserting the next maxillary or mandibular device in the advancements series. The maximum protrusion of the device is 10mm.The Hushd Pro Avera device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps or repositioning elastics.

The EMA 3D is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The EMA 3D device is a simple hardware device. It is an oral appliance and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. The EMA 3D device is intra-oral device used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). It has a patented button hook design with variable elastic band for optimum titration with bitewing if needed. The device consists of two custom fitted trays which fit over the upper and lower dentition of a patient. The trays are standard biocompatible trays that do not reposition teeth. Each tray holds the teeth in their present location not allowing tooth movement. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. There are four button hooks utilized on the EMA 3D device (two hooks per tray, two trays top and bottom. The hooks must be placed at a distance of 21mm apart from the top tray hook to the bottom tray hook center to center. Though there is no requirement except the opitimum location for hook placement between the top and bottom trays is on the upper bicuspid and the lower first molar. Button hooks and bite blocks for the EMA 3D utilize standard dimensions. These button hooks serve as fastening anchors for Elastic Straps that come in four different color coded strengths: White-Soft, Yellow-Medium, Blue-Firm and Clear- Extra Firm. These straps also come in 9 different lengths such that the Dental Professional can ensure the patient specific correct amount of mandibular advancement the lengths are as follows: 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm.

The Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.

The Difiney Anti Snoring device is an intraoral device that is composed of an upper and lower intraoral trays with a handle that is used during the process of customizing the trays. The Difiney Anti Shoring device repositions the jaw anteriorly relative to the maxilla in order to increase the patient's pharyngeal space to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.

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.

The device is intended to aid in the reduction of snoring for adults at least 18 years old.

The Anti-Snore Mouthguard+ is a thermoforming mandibular advancement device to reduce snoring. The device works by pulling the lower jaw forward. As such, the entirety of the device is tissue-contacting. The device combines an upper and lower molding with thermal impression material to conform to user's teeth morphology with an adjustable mechanism to position the user's lower jaw according to the user's need. The Anti-Snore Mouthguard+ is a "Boil and Bite" device where both the upper and lower moldings are constructed out of moldable material when heated in a water bath with rigid frames that allow for the straps to be attached to adjust the fitting. The device additionally comes with a ventilated storage box and Instructions for Use. This ventilated storage box is only provided for storage when the device is not in use and does not impact intended use of the device.

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.

Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older. It 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 subject device, Silent Nite® Sleep Appliance with the Glidewell Hinge™, is a mandibular advancement device (MAD). It holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep. The subject device, Silent Nite® Sleep Appliance with the Glidewell Hinge™, consists of upper and lower trays, and an engaging mechanism made of stainless-steel, which is the Glidewell hinge. Optional orthodontic (elastic) bands are provided as accessories. The trays consist of a soft polyurethane inner layer that provides patient comfort and a hard polyester outer layer for durability. The hinge is adjustable by turning an inner adjustment screw with a hex driver, enabling the amount of mandibular advancement prescribed by the clinician. The design allows for the advancement of the mandible to be adjusted (increased) in 0.25 mm increments up to 10 mm. The subject device, Silent Nite® Sleep Appliance with the Glidewell Hinge™, is customized to conform to the patient's upper and lower dentition based on the clinician's prescription. Upon receipt of the prescription, models for the trays are made and used during the thermoforming fabrication of the upper and lower trays.