Align Technology’s Palatal Expander Gains CE Mark in Europe

Align Technology has received CE marking approval in Europe and registration from the UK’s Medicines and Healthcare Products Regulatory Agency for its Invisalign Palatal Expander System. This 3D-printed device, designed for individuals of all ages, promises to revolutionise orthodontic treatments by addressing common skeletal and dental malocclusions.

Align Technology is setting a new standard in orthodontics with its 3D-printed Palatal Expander System, poised to hit European and UK markets in early 2025. Following its initial success in Australia, New Zealand, Hong Kong, and Singapore, the device is championed for its customisable, patient-specific design, beginning with a digital scan via Align’s iTero intra-oral scanner.

This innovation promises a significant shift from traditional treatments like metal braces, especially benefiting young patients in Phase 1 orthodontic treatment. The dual function of addressing both skeletal and dental arch expansion underscores its comprehensive approach. Align’s CEO, Joseph Hogan, highlighted the strategic expansion as the company broadens its reach in the orthodontic sector, capitalising on the burgeoning demand for practical and efficient orthodontic solutions.

With its European and UK clearance, Align Technology’s Palatal Expander System marks a crucial advancement in orthodontic treatments. By combining this innovative device with Invisalign First aligners, the company offers a holistic solution for early orthodontic intervention. This development not only strengthens Align’s market presence but also promises transformative impacts on orthodontic practises and patient care.

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