Align Technology has received FDA 501(k) clearance for its Palatal Expander System for commercial availability.
The system is intended to be used in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla, according to a Dec. 18 news release from Align.
The expanders are the company's first direct 3D printed orthodontic device and is an alternative to traditional expanders that require manually turning a screw in the mouth every day. Instead, patients receive a series of removable devices staged in small increments of movement.
The Palatal Expander System is available on a limited basis in the U.S. and Canada and is expected to be available in more markets in 2024, the release said.