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Align receives CE Mark in Europe for Invisalign Palatal Expander System
The Fly

Align receives CE Mark in Europe for Invisalign Palatal Expander System

Align Technology (ALGN) announced that it has received CE Mark in Europe under the Medical Device Regulation for Align’s Invisalign Palatal Expander System. The Invisalign Palatal Expander System has also completed registration with MHRA for the United Kingdom and overseas territories. Both approvals are for broad patient applicability, including growing children, teens, and adults. These approvals mark a significant milestone in Align’s efforts to enhance clinical outcomes and efficiency in orthodontics. The Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla with primary, mixed, or permanent dentition during treatment of patients.

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