Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)

The Anti Snoring Mouthpiece is an intraoral device designed to advance the user's lower jaw and maintain that position during sleep, thereby opening the airway to reduce snoring. It is intended for adults 18 years and older and is available in two sizes (Large and Standard) with adjustable jaw advancement from 0 to 6 millimeters.

Both the subject device and predicate (SnoreRx) are mandibular repositioning devices that advance the lower jaw to increase pharyngeal space. The subject device uses polypropylene for hard support while the predicate uses polycarbonate; both use ethylene vinyl acetate copolymer. Both are custom-fitted, reusable intraoral devices with the same advancement capability and desirable characteristics.

ISO 10993-1 for biocompatibility (cytotoxicity, irritation, sensitization); ASTM D790-17 for flexural strength and modulus; ASTM D638-22 for tensile strength and elongation; ASTM D570-22 for water absorption; ASTM D3418-21 for melting temperature; ASTM D792-20 for density.

The L08 series Anti Snoring Mouthpiece is substantially equivalent to the predicate SnoreRx based on identical indications for use, same technological features and intended purpose, comparable materials (both common plastics), identical biocompatibility testing approach, and equivalent physical and mechanical performance specifications. The material difference does not raise safety or effectiveness concerns.