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     213  0 Kommentare Health Canada Issues Updated Medical Device License to Align Technology For the Invisalign Palatal Expander System to Address Skeletal and Dental Expansion

    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 Health Canada issued an updated medical device license to Align for its Invisalign Palatal Expander System*. The updated license is for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques). The Invisalign Palatal Expander System is available on a limited basis in Canada.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231213896980/en/

    Dr. Sandra Tai’s patient independently inserting Invisalign Palatal Expander. (Photo: Business Wire)

    Dr. Sandra Tai’s patient independently inserting Invisalign Palatal Expander. (Photo: Business Wire)

    Previously introduced at the Align Technology Investor Day in September 2023, 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. The Invisalign Palatal Expander is Align’s first direct 3D printed orthodontic device and provides a safe, comfortable, and clinically effective* alternative to traditional palatal expanders that require manually turning a screw in the device in the mouth daily to achieve expansion.

    The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor.** Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero intraoral digital scan. A palatal expansion treatment plan and device design are then developed using Align’s proprietary AI-driven orthodontic software.

    Combined with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment for young patients. Phase 1 treatment is traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted – typically at ages 6 through 10. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion***.

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    Health Canada Issues Updated Medical Device License to Align Technology For the Invisalign Palatal Expander System to Address Skeletal and Dental Expansion 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 …