SHANGHAI — Align Technology, Inc. (Nasdaq: ALGN), a global leader in medical devices for digital orthodontics, has announced that its Invisalign® Palatal Expander System has received regulatory approval from China’s National Medical Products Administration (NMPA). The device, designed for skeletal and dental expansion in children with primary, mixed, or permanent dentition, is expected to be commercially available in China in the second half of 2025.
The approval marks a key milestone for Align in its mission to improve clinical outcomes and streamline orthodontic treatments using digital innovations.
The Invisalign Palatal Expander System is a next-generation orthodontic device created through direct 3D printing, based on Align’s proprietary and patented technology. It is designed to rapidly expand and stabilize the upper jaw (maxilla) in pediatric patients undergoing orthodontic treatment. Each device is custom-built using a digital scan from Align’s iTero™ intraoral scanner and tailored to the patient’s anatomy through Align’s proprietary software.
“This system reflects our commitment to transforming orthodontic care through digital innovation,” said David Carr, Executive Vice President and Managing Director of Align Technology, Asia Pacific. “With NMPA’s approval, we are thrilled to introduce our first 3D printed orthodontic appliance to doctors and patients in China.”
Chinese orthodontists are already expressing strong interest in the system. Dr. Cheng Hui, Early Orthodontics Leader at Keen Group in Shandong, said, “With this new expander, I can soon offer younger patients a more comfortable and effective early treatment. Hearing the positive outcomes from peers in other markets increases my confidence in its benefits.”
The system uses a series of removable appliances that gradually expand the upper jaw in small increments, according to a plan set by the patient’s orthodontist. The custom devices are digitally designed to align with the child’s growth and treatment goals.
Dr. Yuan Gongjie of Shanghai Children’s Hospital, Shanghai Jiao Tong University School of Medicine, noted, “Having access to this innovative system will help us deliver more effective and comfortable early interventions for children. The successful cases in other countries give us confidence in its clinical value.”
Align’s early intervention platform now includes both Invisalign First™ clear aligners and the Palatal Expander System, offering a comprehensive solution for Phase 1 treatment. Phase 1 refers to early interceptive orthodontic care typically provided between the ages of 6 and 10, before the full eruption of permanent teeth. Traditional Phase 1 treatments often involve metal braces or fixed expanders.
Invisalign First aligners are specifically engineered to manage developing teeth, accommodate shorter crowns, and enable predictable dental arch expansion in young patients.
“About 20% of orthodontic cases each year begin with early intervention—and this number continues to grow,” said Dr. Mitra Derakhshan, Executive Vice President and Chief Clinical Officer of Align Technology. “With the addition of Invisalign Palatal Expanders, we now offer doctors a comprehensive toolkit to address both skeletal and dental issues in growing patients. Together with mandibular advancement features, our solutions enable precise treatment of jaw imbalances and bite issues during adolescence.”
Align Technology continues to expand its digital orthodontic offerings across the Asia-Pacific region, with China now positioned to benefit from the company’s latest innovations in pediatric orthodontic care.
