Sleep Science Partners, Inc.

Sleep Science Partners, Inc. specializes in mandible-repositioning sleep-disordered breathing orthoses. These are custom-fitted oral appliances designed to reposition the jaw, helping to improve airway patency during sleep. The devices are intended for treating conditions like obstructive sleep apnea and are available for both prescription and over-the-counter use.

Sleep Science Partners, Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the provided data.

The devices manufactured by Sleep Science Partners, Inc. are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track medical devices that have undergone the necessary regulatory processes, such as 510(k) clearance, to demonstrate substantial equivalence to a legally marketed predicate device.

Sleep Science Partners, Inc.’s mandible-repositioning orthoses fall under Class II classification according to FDA regulations. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, though they do not pose a high risk like Class III devices. This classification reflects the moderate risk associated with these oral appliances when used for treating sleep-disordered breathing.