US-based medical device company Align Technology has received the US Food and Drug Administration (FDA) 510(k) approval for its Invisalign Palatal Expander System.

The Invisalign Palatal Expanders are intended for rapid expansion and holding of skeletal and dental narrow maxilla with primary, mixed, or permanent dentition during the treatment.

The system contains a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor.

Initially introduced in September this year, the Invisalign Palatal Expander System is an advanced direct 3D printed device that works based on Align’s patented technology.

It is the company’s first direct 3D printed orthodontic device, designed to provide a safe, comfortable, and clinically effective alternative to traditional palatal expanders.

Align said that the FDA approval is applicable for a broad spectrum of patient populations, including growing children, teens, and adults with surgery or other techniques.

Align Technology senior product research and development vice president Srini Kaza said: “Our latest innovation in digital orthodontics based on proprietary and patented technology that builds on many industry firsts designed for the 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.”

The Invisalign Palatal Expander System devices are directly 3D printed and are customised according to the patient’s unique anatomy based on an iTero intraoral digital scan.

The company’s unique AI-powered orthodontic software will help develop a palatal expansion treatment plan and support the device design.

Together with Invisalign First aligners, Invisalign Palatal Expanders will provide doctors with an early intervention orthodontic treatment for young patients (Phase 1 treatment).

Traditionally, the Phase 1 treatment is delivered through arch expanders or partial metal braces before all permanent teeth have erupted, between six and 10 years of age.

Invisalign First clear aligners are designed to address a wide range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion.

Align is commercialising the Invisalign Palatal Expander System in Canada and the US, on a limited basis, with plans to offer it in other markets starting in 2024.

Invisalign Palatal Expander clinical trial participant Don Spillers said: “The Invisalign Palatal Expander System worked very well clinically, we had fewer emergencies and less chair time than we did with traditional expanders.

“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.”

Align Technology global clinical senior vice president Mitra Derakhshan said: “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.”