Align Technology (ALGN) said Wednesday its Invisalign Palatal Expander System has been granted a CE mark in Europe.
The 3D-printed orthodontic device has also completed registration with the UK Medicines and Healthcare Products Regulatory Agency and overseas territories, the company said.
The approvals cover broad patient applicability from children to adults, it said.
The company said the device will be commercially available across Europe, the Middle East and Africa in Q1 2025.
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