Align Technology, Inc., a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced that Align's Invisalign Palatal Expander System has been approved by the National Medical Products Administration (NMPA) in China. The Invisalign Palatal Expander is applicable to skeletal and dental malocclusion in primary, mixed and permanent dentition and will be commercially available during second half of 2025.

This approval marks another significant milestone in Align’s efforts to enhance clinical outcomes and efficiency in orthodontics.

The Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during treatment of patients.

“The Invisalign Palatal Expander System exemplifies our commitment to advancing digital orthodontics with innovative solutions that enhance patient treatment experiences,” said David Carr, Align Technology executive vice president and managing director, Asia Pacific. “We are excited to extend the availability of the transformative Invisalign Palatal Expander system, Align’s first direct 3D printed orthodontic appliance, to even more doctors and their patients markets across the Asia Pacific region. Now with the NMPA approval, soon we will be able to also offer this innovation to our doctor customers in China.”

“With the upcoming availability of Invisalign® Palatal Expander in China, I will soon be able to offer end-to-end comfortable early intervention solutions to my younger patients. Seeing the great clinical outcomes shared by my peers in other markets only heightens my enthusiasm for what this means for my patient care,” shared Dr. Cheng Hui, leader of Early Orthodontics at Keen Group, Shandong, China.

The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor. Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero™ intraoral digital scan. A palatal expansion treatment plan and device design are then developed using Align’s proprietary orthodontic software.

Dr. Yuan Gongjie, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, China added, “With Invisalign® Palatal Expander coming to China market soon, I will soon be able to offer complete early intervention solutions that focus on both effectiveness and comfort for children. Learning about the great outcomes of this product from my peers in other markets gives me even greater confidence in the benefits this product can bring to my younger patients.”

With Invisalign First™ aligners and Invisalign Palatal Expanders, Align Technology can provide doctors with a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment for young patients. Phase 1 treatment is traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted – typically at ages 6 through 10. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion.

“Phase 1 or early interceptive treatment accounts for 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align Technology Executive Vice President, Chief Clinical Officer, Global Treatment Planning and Clinical Services. “Together with Invisalign First aligners, Invisalign Palatal Expanders enables Align Technology to provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children. The addition of mandibular advancement features to Invisalign aligners also provides doctors with more options for treating skeletal and dental jaw imbalances and bite correction for their growing patients during their teenage years.”