The approval of the Invisalign® Palatal Expander System by China’s National Medical Products Administration (NMPA) represents a pivotal moment in pediatric orthodontics. With malocclusion and narrow upper jaws affecting millions of children globally, early intervention is critical to long-term oral health and facial development. Traditional expansion methods often involve uncomfortable metal devices and invasive procedures that can hinder compliance, especially in young patients. Align Technology’s entrance into this space with a modern, patient-friendly device introduces a new standard of care that prioritizes both clinical outcomes and comfort.

The Invisalign Palatal Expander System is Align’s first direct 3D-printed orthodontic appliance and utilizes proprietary digital technology to customize each device based on the patient’s anatomy. Using iTero™ intraoral scans and Align’s orthodontic software, doctors can plan precise, gradual palatal expansion through a series of removable devices. Unlike traditional appliances, this system is non-invasive, easy to use, and designed for skeletal and dental expansion across primary, mixed, and permanent dentition. It offers a breakthrough in delivering predictable and effective results without the need for fixed hardware or metal braces in the early stages of orthodontic care.

This launch solidifies Align Technology’s role as a leader in digital orthodontics, now extending its innovation to Phase 1 treatment solutions. With the combination of Invisalign First™ aligners and the newly approved Palatal Expander, orthodontists in China will soon be equipped to provide a fully digital, end-to-end early intervention treatment pathway. As demand for child-friendly, non-invasive orthodontic options grows, this system is poised to revolutionize care for young patients—ushering in a new era of comfort, accuracy, and accessibility in early orthodontic intervention.

MedTech Spectrum's Summary

Regulatory Milestone: Align Technology’s Invisalign® Palatal Expander System has received approval from China’s National Medical Products Administration (NMPA), enabling access to a modern, non-invasive solution for early orthodontic treatment in a major global market.

Innovative Design: The system is Align’s first direct 3D-printed orthodontic appliance, customized using iTero™ digital scans and proprietary software to gradually expand a child’s upper jaw with precision and comfort—without traditional metal braces or fixed devices.

Enhanced Early Intervention: By combining the Palatal Expander with Invisalign First™ aligners, Align now offers a complete digital treatment solution for Phase 1 orthodontics, addressing both skeletal and dental malocclusions in growing patients with improved clinical outcomes and patient experience.