WASHINGTON (dpa-AFX) - 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.



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