Align Tech's Invisalign Palatal Expander System Receives FDA 510(k) Clearance

(RTTNews) - Align Technology, Inc. (ALGN) on Monday, announced that its latest orthodontic device, the Invisalign Palatal Expander System, has received FDA 510(k) clearance for commercial use in the U.S. for a wide range of patients, including children, teens, and adults (with surgery or other techniques).

The Invisalign Palatal Expander is the first direct 3D-printed orthodontic device from Align, offering a safe, comfortable, and clinically effective alternative to traditional palatal expanders.

Align stated that each direct 3D printed device is customized based on an iTero intraoral digital scan for the patient, which ensures precision and accuracy in the device's design and fit.

The Invisalign Palatal Expander is an essential component of Align's Invisalign First aligners, providing doctors with a full early intervention treatment solution for Phase 1 treatment, which is an early interceptive orthodontic treatment for young patients.

The device is already available on a limited basis in Canada and the U.S. and is expected to be available in other markets pending regulatory approvals starting in 2024.