Align Technology, Inc. announced that Align's Invisalign Palatal Expander System has been included in the Australian Register of Therapeutic Goods and the New Zealand Web Assisted Notification of Devices Database (WAND), and is commercially available in both Australia and New Zealand. The ARTG and WAND entries for Invisalign Palatal Expender System cover broad patient applicability, including growing children, teens and adults (with surgery or other techniques). 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 System 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 proprietary AI-driven orthodontic software. Combined with Invisalign First?

aligners, Invisalign Palatal Expanders 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 specifically to address a broad range of younger patients? malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion. The Invisalign Palatal Expander System is now available in Australia and New Zealand.

It is expected to be available in other APAC markets pending regulatory approvals starting in 2024.