• Invisalign Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders.
• With Invisalign First aligners and Invisalign Palatal Expanders, Align Technology now provides doctors with a full early intervention treatment solution, including both skeletal (orthopedic) and dental (orthodontic) arch expansion.
• The Invisalign Palatal Expander System has also completed registration with the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA).
• Both approvals are for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques).

Align Technology, Inc. ("Align") (NASDAQ:ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign System of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced that it has received CE Mark in Europe under the Medical Device Regulation (MDR 2017/745) 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 (with surgery or other techniques).

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 (upper jaw) with primary, mixed, or permanent dentition during treatment of patients.