Press release
Align Technology Receives US FDA 510(k) Clearance for the Invisalign® Palatal Expander System to Address Skeletal and Dental Expansion in Growing Patients, Including Teenage Patients Which Represent the Majority of Orthodontic Case Starts Globally
Invisalign® Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders. Combined with
About this update from Align Technology, Inc.
[{"type":"text","content":"\n\nInvisalign® Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders.\n\n\n\n\nCombined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution, including both skeletal (orthopedic) and dental (orthodontic) arch expansion.\n\n\n\n SAN JOSE, Calif. & TEMPE, Ariz.--(BUSINESS WIRE)--\nAlign 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 the U.S. Food and Drug Administration (FDA) has cleared Align’s Invisalign® Palatal Expander System* for commercial availability in the U.S. The FDA 510(k) clearance is for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques).\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231218813291/en/A young patient independently inserting Invisalign® Palatal Expander- courtesy of Dr. David Walt, Vaughan, Ontario, Canada\nPreviously 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.\n\n\nSpeaking at the company’s 2023 Investor Day in Las Vegas, Srini Kaza, Align senior vice president of product research & development said, “I am very proud to unveil the Invisalign Palatal Expander System, our latest innovation in digital orthodontics based on proprietary and patented technology that builds on many industry firsts designed for treatment of children and teens, including I...