ZSmile System

The ZSmile System is an orthodontic device that adjusts patients' teeth through pulsatile mechanical force from a pneumatic mouthpiece. It is designed for approximately 10 hours of daily use (typically at night) and is suitable for adolescents and adults with a full complement of permanent teeth requiring upper, lower, or combined jaw treatments.

The ZSmile System adds a mobile application and cloud connectivity, a wireless Qi charging option, and replaces the predicate's diaphragm pump with an electronic piston pump to reduce device size and noise. The fundamental operation—balloon inflation within the mouthpiece applying pulsatile pressure—remains identical to the predicate Aerodentis System.

Software validation per FDA guidance on device software functions; electrical safety per IEC 60601-1; electromagnetic compatibility per IEC 60601-1-2 and IEC 60601-1-11 for home use; wireless communication testing per EN 301 489 and EN 303 417.

The modified ZSmile System is substantially equivalent to the cleared Aerodentis System because it maintains the same fundamental design, technology, function, materials, operating principle, and indication for use. Minor differences (cloud connectivity, wireless charging, pump redesign) do not raise new safety or effectiveness questions and met predicate acceptance criteria in performance testing.