213 0 Kommentare 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

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 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).

This 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

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.

Lesen Sie auch

MDAX-Perle

Das ist Deutschlands Rekordhalter bei Dividendenerhöhungen

gestern 14:54

Unter 100 Euro zugreifen?

Plus 12 Prozent: Darum ist Gerresheimer der Gewinner des Tages

23.05.24, 14:31

"Lieber Nasdaq kaufen"

Cathie Woods ARK-Fonds fährt Verluste ein, hinkt Markt hinterher

21.05.24, 11:49

Im Fokus

2 Gesundheits- und Wachstumswerte mit attraktiver Bewertung

18.05.24, 16:00

Speaking 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 Invisalign treatment with Mandibular Advancement and Invisalign First aligners. It is extremely rewarding for our team of engineers and material scientists to produce Align’s first directly fabricated orthodontic appliance and pave the way for future innovation using direct 3D printing technology that enables more sustainable and efficient solutions.”

Seite 1 von 4

Seite 2 ►