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Align Technology wins FDA nod for Invisalign palatal expander system

Align Technology (Nasdaq:ALGN) announced today that the FDA granted 510(k) clearance for its Invisalign palatal expander system.

The direct 3D-printed device provides rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw). It enables primary, mixed or permanent dentition during the treatment of growing patients.

FDA clearance covers broad patient applicability, including growing children, teens and adults (with surgery or other techniques).

Align Technology unveiled the technology at its September Investor Day event. The palatal expander — Align’s first direct 3D-printed orthodontic device — provides a safe, comfortable and clinically effective alternative to metal palatal expanders. Those devices requires manually turning a screw in the device in the mouth daily to achieve expansion.

The expanders feature a series of removable devices staged in small increments of movement to expand a narrow maxilla. Each 3D-printed device is customized to a patient’s unique anatomy based on an iTero intraoral digital scan. Align Technology’s proprietary AI-driven orthodontic software then develops a treatment plan and device design.

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