Align Technology — a 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 received CE mark in Europe under the Medical Device Regulation (MDR 2017/745) for Align’s Invisalign palatal expander system.
The Invisalign palatal expander system has also completed registration with Medicines and Healthcare products Regulatory Agency (MHRA) for the UK and overseas territories. It is expected to be commercially available across Europe, Middle East and Africa (EMEA) in Q1 2025.
Both approvals are for broad patient applicability — including growing children, teens, and adults; with surgery or other techniques. These approvals mark a milestone in Align’s efforts to enhance clinical outcomes and efficiency in orthodontics.
The Invisalign palatal expander system is a direct 3D printed device and consists of 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.
Each direct 3D printed device is customised to the patient’s unique anatomy based on an iTero intraoral digital scan. A palatal expansion treatment plan and device design are then developed using Align’s orthodontic software.
The Invisalign palatal expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental upper jaw with primary, mixed, or permanent dentition during treatment of patients.
With Invisalign First aligners and Invisalign palatal expanders, Align Technology can provide doctors with a full early intervention treatment solution for phase 1 treatment — an early interceptive orthodontic treatment for young patients.
Phase 1 treatment is traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted — typically at ages 6 through 10. Invisalign First clear aligners are designed to address a range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion.
“Phase 1 or early interceptive treatment accounts for 20% of orthodontic case starts each year and is growing,” said Dr Mitra Derakhshan, Align Technology executive vice-president, chief clinical officer.
“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,” Dr Derakhshan added.
“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.”
Simon Beard, Align Technology executive vice-president and managing director, EMEA, said, “We are thrilled to extend the availability of this transformative alternative to traditional palatal expanders to doctors and their patients across the EMEA region.”
