Align Technology, Inc. announced on May 15, 2025, that its Invisalign Palatal Expander System has received approval from the National Medical Products Administration (NMPA) in China. This regulatory clearance marks a significant milestone for Align's efforts to enhance clinical outcomes and efficiency in orthodontics within the Chinese market.
The Invisalign Palatal Expander is applicable for skeletal and dental malocclusion in primary, mixed, and permanent dentition, offering a modern and innovative direct 3D-printed device. Commercial availability of the system in China is expected during the second half of 2025.
This approval extends the availability of Align’s first direct 3D-printed orthodontic appliance to a crucial market in the Asia Pacific region. It provides doctors in China with an end-to-end early intervention solution, combining with Invisalign First aligners to treat common skeletal and dental malocclusions in growing children.
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