SleepRight Snore Aid

The SleepRight Snore Aid is an intraoral mandibular advancement device (MAD) that moves the lower jaw forward to open the airway and reduce snoring and obstructive sleep apnea. It consists of two moldable thermoplastic trays fitted over the upper and lower teeth, with an adjustable stop mechanism on the upper tray that provides 1mm incremental advancement up to 6mm total. It is marketed in both over-the-counter (for snoring reduction) and prescription (for mild to moderate OSA and/or snoring) versions.

The SleepRight Snore Aid uses the same injection-molded thermoplastic design, materials (polycarbonate, ethylene vinyl acetate, polypropylene, polycaprolactone), and 1mm incremental adjustment mechanism as its predicates. The key difference is the fitting method: it requires 150°F warm water versus 212°F boiling water for molding. All devices are non-sterile, reusable, single-user intraoral devices intended for long-term mucosal contact.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation) for biocompatibility; ASTM D790 (flexural strength), ASTM D638 (tensile strength), ASTM D695 (compressive strength), ASTM D2240 (surface hardness), ASTM D570 (water sorption), and ASTM D896 (water solubility) for material physical properties.

The device is substantially equivalent because it shares identical design (two-piece adjustable MAD), materials, and intended use with predicate devices SnoreRx and Apnea Rx Pro. The materials have passed the same ISO 10993 biocompatibility tests as predicates, and the mechanical properties meet ASTM standards via manufacturer data sheets. The only technological difference—warm water versus boiling water fitting—does not affect safety or efficacy. Clinical testing was waived based on design and material equivalence to legally marketed predicates.