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Align Technology Gets FDA Approval for Invisalign Palatal Expander

December 19, 2023

Align Technology, Inc. has received FDA clearance for its Invisalign Palatal Expander System, marking a significant development in orthodontic treatment options. This system, which is the company’s first directly 3D printed orthodontic device, offers a modern alternative to traditional palatal expanders. It is designed for a wide range of patients, including children, teens, and adults, addressing both skeletal and dental malocclusions.

Align Technology Gets FDA Approval for Invisalign Palatal Expander
A patient inserting the 3D printed expander. (Image Credit: David Walt)

The Invisalign Palatal Expander utilizes Align’s proprietary technology, including AI-driven orthodontic software and iTero intraoral digital scans. This technology allows for the creation of custom-fit devices tailored to individual patient anatomy. Each expander is staged in small increments, enabling precise control over the expansion process. This method is more comfortable and hygienic than traditional expanders, as it eliminates the need for manual screw adjustments.

Orthodontists have noted the system’s clinical effectiveness and ease of use, leading to fewer emergencies and reduced chair time. It integrates with Invisalign First aligners, providing a comprehensive solution for early intervention orthodontic treatments. This approach is particularly beneficial for young patients, who traditionally undergo treatment with partial braces or arch expanders.

By leveraging direct 3D printing technology and AI-driven software, this system offers a more efficient and patient-friendly alternative to traditional methods. Future developments in this field may continue to enhance orthodontic practices, further integrating digital technology and personalized care.

The Invisalign Palatal Expander System is currently available in the U.S. and Canada on a limited basis, with plans for expansion to other markets following regulatory approvals.

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About the author | Phillip Keane
Phillip is an aerospace engineer from UK. He is a graduate of Coventry University (UK), International Space University (France) and Nanyang Technological University (Singapore), where he studied Advanced Manufacturing at the Singapore Centre for 3D Printing.
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