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The MICRODENTAL, Inc. Micr02 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Optionally, if the DentiTrac® micro-recorder is completely embedded in the MicrO2 device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System

The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps or repositioning elastics. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear. The Micr02 OSA device with Micro-recorder is identical to the primary predicate device, Somnomed with Micro-Recorder except for the difference in the adjustment mechanism. The MicrO2 uses twin mated posts to adjust whereas the Somnomed uses embedded screws. Without the compliance chip the subject device is identical in materials and manufacturing to the reference predicate MicrO2 OSA device. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new concerns. This submission adds the option for any clinician to decide to incorporate a DentiTrac® Microrecorder compliance chip embedded into a MicrO2 OSA device to record a patient's compliance to the prescribed oral appliance therapy. The MicrO2 OSA device with Micro-recorder is to be used in combination with the DentTrac® System which includes a base station at the provider's office used to upload the data from the chip to a web application for cloud based reporting and tracking. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. This is the identical chip that is included in the predicate device – the Somnodent with Micro-Recorder. The inclusion of the embedded DentiTrac® micro-recorder, provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles of the Micr02 OSA device as established by the reference device, the MicrO2 OSA without the DentiTrac® Micro-recorder.

The MICRODENTAL, Inc. MicrO2 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together alleviate snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps or repositioning elastics. The maximum protrusion of a MicrO2 archform is 6mm, which is comparable to the predicate device's 6mm advancement screw, measuring from plate to plate. This also negates the need for patients utilizing external controlling components such as keys, screwdrivers or ligature ties. The maximum protrusion of a MicrO2 archform is 6mm, which is comparable to the predicate device. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear. The Micr02 OSA device is identical to the Somnomed MAS RXA (Classic) except for the difference in the adjustment mechanism. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new safety concerns.