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.