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Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

The Respire Pink AT (Hard, Hard/Soft, EF) is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Pink AT (Hard, Hard/Soft, EF) is made out of dental industry standard acrylic resins & metals, and is custom designed to comfortably fit each patients' unique oral anatomy.

The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older. Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. The micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® system.

The Respire Pink Series with DentiTrac® refers to two devices: Respire Pink Series-Herbst and the Respire Pink Series-Herbst-EF, herein referred to collectively as Respire Pink Series. These devices function as mandibular advancement splints which hold the jaw in a forward position. The forward jaw placement moves the tongue and pharyngeal tissue into a position to help maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). Respire Pink Series appliances are customizable devices which are produced according to the individual patient anatomy and prescription. The Respire Pink Series-Herbst consists of full hard acrylic upper and lower fitting surfaces, and the Respire Pink Series-Herbst-EF consists of hard acrylic fitting side plates and chrome (BEGO Wironit®) upper palatal and lower lingual plates. The Herbst hardware on the side of the device allows for forward and lateral jaw movement while restricting backward jaw movement, and allows the patient to open and close the mouth. The Herbst hardware contains an expansion screw for mandibular position adjustment, and is attached to the appliance using medical grade stainless steel fixing elements and screws. This submission is to provide clinicians the option to incorporate a Braebon DentiTrac® micro-recorder into a Respire Pink Series device. The micro-recorder is encapsulated in Loctite epoxy and fully encased into the device acrylic, and is not patient contacting. The micro-recorder is utilized to track patient compliance to prescribed oral appliance therapy by collecting data for wear-time through oral temperature, movement tracking, and head position. The data can be uploaded to a cloud-based web application using the DeniTrac® system which allows clinicians to review the patient data. The inclusion of the microrecorder provides additional treatment information to clinicians without effecting the operating principles of the Respire Pink Series devices.

The Respire Blue Scries - EF is indicated to treat mild to moderate OSA (Obstructive Sleep Apnea)

The Respire Blue Series – EF (Endurance Frameworks) – is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates / trays) and chrome - Wironit material (upper / Palatal and lower / Lingual plates / trays). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which are used to hold elastic bands which guide the jaw to the desired position. In addition there are expansion screws inside the Acrylic side plates / trays that allows for device expansion based on patient needs. The upper and lower components are connected by an adjustable hinge, thus the patient can open and close the mouth while wearing the appliances

The Respire Pink Series - Herbst - EF is indicated to treat mild to moderate OSA.

The Respire Pink Series - Herbst - EF (Endurance Frameworks) - is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates) and chrome - Wironit material ( upper / Palatal and lower / Lingual plates). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which allows the device to be tightened if it becomes loose. The device is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a position to help maintain an open airway, which helps in the treatment of snoring and mild to moderate obstructive sleep apnea. The Herbst hardware on the side of the device allows the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device. The upper and lower components are connected by an adjustable hinge, thus patient can open and close while wearing the appliances.