Align Technology receives FDA clearance for the Invisalign Palatal Expander System to address skeletal and dental expansion in growing patients  

Align Technology, 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, has announced that the US Food and Drug Administration (FDA) has cleared Align’s Invisalign Palatal Expander System for commercial availability in the US The FDA clearance is for broad patient applicability, including growing children, teens and adults (with surgery or other techniques). 

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 and comfortable 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 worked very well clinically, we had fewer emergencies and less chair time than we did with traditional expanders,” said Dr Don Spillers, an orthodontist and participant in an Invisalign Palatal Expander clinical trial. “The experience has definitely been much better for my patients with the Invisalign Palatal Expander System, as there was no cementing of bands, no fitting of a metal expander and no screw to turn. All of the parents were happy and their kids were cooperative.”