Align Technology has received CE mark clearance for its Invisalign palatal expander system. It also completed registration with MHRA for the UK and overseas territories.

Both approvals cover a broad range of patients, including growing children, teens, and adults. The Invisalign palatal expander gained U.S. Food and Drug Administration (FDA) clearance in December 2023.

The system is a modern, direct 3D printed device based on proprietary, patented technology. Invisalign palatal expanders are intended for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla with primary, mixed, or permanent dentition.

It consists of a series of removable devices staged in small increments of movement to expand a narrow maxilla. Each direct 3D printed device is customized to unique anatomy based on an iTero intraoral digital scan. A palatal expansion treatment plan and device design are then built using Align’s orthodontic software.

The system is anticipated to be commercially available across the EMEA region in Q1 2025.

“Phase 1 or early interceptive treatment accounts for 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align Technology executive vice president and chief clinical officer. “Together with Invisalign First aligners, Invisalign Palatal Expanders enables Align Technology to provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children. The addition of mandibular advancement features to Invisalign aligners also provides doctors with more options for treating skeletal and dental jaw imbalances and bite correction for their growing patients during their teenage years.”