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The myTAP2 is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

The myTAP2 is an oral appliance design concept based upon the use of a standard set of upper and lower travs filled with an impression material. A screw is used to advance the lower tray. The myTAP2 is of a design often referred to as a "Boil and Bite" and the concept of advancement is commonly referred to as a Mandibular Repositioning Device (MRD).

The TAP(r) family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years or age or older. The DentiTrac(t) micro-recorder is completely embedded into the TAP(r) intra-oral appliance, the micro-recorder is intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac(t) System.

Airway Management, Inc. has a family of intra-oral appliances known and referred to as the Thornton Appliance Positioner ("TAP®") family. There have been a number of 510(k) clearances and the TAP® versions are all fundamentally the same. They are: - Separate upper and lower trays - Contain trays custom fitted to each patient - Have a coupling mechanism (single point midline) that allows adjustment by way of incremental advancement of the mandible - Allows the sleep specialists to titrate the advancement for optimum treatment effect - Both Customized trays and Standard sized trays - Mandibular advancement acts to increase the patient's pharyngeal space during sleep. This submission is to offer the option of an embedded micro-recorder, DentiTrac® which will record and track a patient's compliance to the prescribed oral appliance therapy. The DentiTrac® can be incorporated into any of the TAP® family of intraoral appliances. The DentiTrac® micro-recorder monitors the wear time through oral temperature, tracks movements, and head position. The DentiTrac® provided information when used with the DentiTrac® System. During scheduled visits, the DentiTrac® data can be transferred to a cloudbased web application for reporting and tracking. The addition of the DentiTrac® does not alter the principle of operation, technological characteristics, or safety of the TAP® family of intraoral appliances, which are the reference devices.

The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.

The TAP PAP Nasal Pillow Mask consists of a boil & bite type dental appliance. A small bracket that extends beyond the lips to attach the mask frame (Mask - Upper Mouth Piece Adjustment Joint). Two soft silicone nasal pillows are located on the mask frame to seal against the nostrils. The nasal pillows come in three sizes and can be individually rotated to align with the user's nares. A corrugated flexible tube extends upwards from the mask frame to a 22 mm connector which connects to a breathing tube of a CPAP or bi-level device. The mask frame has exhalation vents (bias holes) that allow exhaled gases to be continually flushed.