Align Technology—maker of Invisalign clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry—has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Invisalign palatal expander system for children, teens, and adults.
 
The Invisalign palatal expander is a direct 3D-printed device and is for rapid expansion and holding of skeletal and/or dental narrow maxilla with primary, mixed, or permanent dentition. It is Align’s first direct 3D-printed orthodontia device and the company hopes it will be an alternative to traditional palatal expanders, which need manual screw turning in the mouth daily to achieve expansion.
 
Instead, the expanders consist of a series of removable devices staged incrementally to expand a narrow maxilla to a position determined by the treating doctor. The company’s iTero intraoral digital scanner creates devices customized to each patient’s anatomy. A treatment plan and device design are then built using Align’s AI-driven orthodontic software.
 
Combined with Invisalign First aligners, the palatal expanders provide doctors with a full early intervention treatment solution for Phase 1 treatment, an early interceptive orthodontic treatment for young patients, the company said.
 
“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr. Mitra Derakhshan, Align’s senior VP of Global Clinical. “Together with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children. The addition of mandibular advancement features to Invisalign aligners also provides doctors with more options for treating skeletal and dental jaw imbalances and bite correction for their growing patients during their teenage years.”
 
Kaza, Align senior VP of product research & development added, “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.”