Align Technology Secures CE Mark for Invisalign Expander

Align Technology has achieved a CE mark under MDR for its groundbreaking Invisalign palatal expander system, the first direct 3D-printed orthodontic device in its portfolio. The device also gained MHRA registration for the UK, enabling treatment for a broad range of patients, including children, teens, and adults with additional interventions like surgery.

The innovative expander addresses dental and skeletal narrow maxilla issues through staged, removable aligners tailored to each patient’s anatomy using Align’s proprietary AI-driven software. This system offers a comfortable and efficient alternative to traditional metal expanders, which rely on manual adjustments. Unveiled at Align’s September Investor Day, it promises enhanced treatment experiences and expanded availability across the EMEA region in early 2025.