FDA clears align technology’s invisalign palatal expander system

Align Technology announced in December of 2023 that the U.S. Food and Drug Administration (FDA) has officially granted 510(k) clearance to its Invisalign Palatal Expander System.  The FDA 510(k) clearance is mainly for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques.

In short, this means that this product can now be made available commercially in the U.S. The device was also recently approved by Health Canada for use in Canada.

Align Technology, Inc. is a leading global medical device company known for its innovative products in the dental industry. They design, manufacture, and sell various products such as the iTero™ intraoral scanners, exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, and perhaps the most recognized product from Align, the Invisalign® aligner system.

On September 6th, 2023, Align launched the Invisalign Palatal Expander System, a modern and innovative direct 3D-printed device based on proprietary and patented technology.

Why is this significant?

To understand the revolutionary vision of Align with their new Invisalign Palatal Expander System, we must first familiarize ourselves with what a classic palatal expander is. A palatal expander is a medical device that is used to widen narrow upper jaws so that the bottom and upper teeth fit together better. Orthodontists recommend a palatal expander for cases where crossbite, overcrowded teeth, and other bite anomalies cannot be corrected simply using traditional metal braces.

Depending on the age and severity of the condition, one may be required to wear a palatal expander for a few weeks, several months, or even up to one year. The Invisalign Palatal Expander System differs from the conventional palatal expanders because this system expands the upper jaw entirely using direct 3D printing 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 the 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. This novel approach eliminates the need for manual adjustments as would be involved in the treatment with conventional palatal expanders.

The Invisalign Palatal Expanders work through a series of staged, removable devices that gradually widen the upper jaw (maxilla) in small, controlled increments. This makes the process much more comfortable and precise than traditional palatal expanders. Since each of the direct 3D printed devices is customized to the patient’s unique anatomy based on an iTero intraoral digital scan, this system ensures accurate outcomes with faster results.

“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,” said Dr. Mitra Derakhshan, SVP, of global clinical. “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.”

Combined with Invisalign First Aligners for kids, Invisalign Palatal Expanders allow dentists to provide full early intervention treatment solution for Phase 1 treatment, which starts at the age of 6. Interceptive treatments early on through palatal expanders or partial metal braces ensure that that child’s teeth develop ideally and prevent the need for expensive and more complex orthodontic and restorative treatment in the child’s future.