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The ZSmile System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.

The ZSmile System is an orthodontic system intended to adjust the patient's teeth through movement from their initial position to the desired position as a result of pulsatile mechanical force.

The device is designed to achieve orthodontic tooth movement over a period of approximately 10 hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments.

The modifications from the cleared system include:

Adding mobile application and cloud:
The mobile application is intended to provide the device pairing information with the ZSmile cloud for it to be able to communicate with the patient's smartphone via patient's local Wi-Fi. The ZSmile Cloud is hosted on AWS supports ZSmile device registration using unique hardware identifiers and securely stores Wi-Fi credentials to enable reliable connectivity. The cloud contains non-medical functions such as a database for storing session data, logs, and device usage information.

Additional charging option:
Addition of option for charging by Qi-compatible wireless charging pad (not supplied).

Pump redesign:
The ZSmile device uses an electronic piston pump whereas the predicate Aerodentis System incorporated an electronic diaphragm pump as the internal pressure-generation element.

Both pump types operate as electrically driven, self-contained air compression modules intended to supply pulsatile pneumatic pressure to the mouthpiece. The redesign was made to reduce the overall size of the PTC unit and to lower pump operation noise levels.

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