In addition to CE mark under MDR, the palatal expander completed registration with MHRA for the UK and overseas territories. Approvals cover broad patient applicability, including growing children, teens and adults (with surgery or other techniques).
The direct 3D-printed device provides rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw). It enables primary, mixed or permanent dentition during the treatment of growing patients. The system won FDA clearance in December 2023.
Align Technology unveiled the technology at its September Investor Day event. The palatal expander — Align’s first direct 3D-printed orthodontic device — provides a safe, comfortable and clinically effective alternative to metal palatal expanders. Those devices requires manually turning a screw in the device in the mouth daily to achieve expansion.
The expanders feature a series of removable devices staged in small increments of movement to expand a narrow maxilla. Each 3D-printed device is customized to a patient’s unique anatomy based on an iTero intraoral digital scan. Align Technology’s proprietary AI-driven orthodontic software then develops a treatment plan and device design.
Align Technology plans to make the system available across EMEA in the first quarter of 2025.
“The Invisalign Palatal Expander is an example of Align’s continuous commitment to innovative digital orthodontics by delivering products with greater efficiency for doctors and better treatment experiences for young patients,” said Simon Beard, Align Technology EVP and managing director, EMEA. “We are thrilled to extend the availability of this transformative alternative to traditional palatal expanders to doctors and their patients across the EMEA region.”
