Invisalign® Palatal Expander system receives U.S. FDA 510(k) clearance

• During Q4’23, we announced that the U.S. Food and Drug Administration cleared IPE for commercial availability in the U.S. The FDA 510(k) clearance is for broad patient applicability, including growing children, teens, and adults
• Full early intervention treatment such as Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing. Together with Invisalign First aligners, IPE 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. Essentially, we now have an Invisalign digital treatment solution for every phase of treatment.

Invisalign® Palatal Expander System is intended for broad patient applicability, including adults when coupled with surgery or other techniques as deemed appropriate by the treating orthodontist. It is indicated for this use in Canada and the U.S. where it is available for sale, and we recently received regulatory clearance in Australia and New Zealand, and we anticipate that we will begin commercialization in Q2’24. It is expected to be available in other markets pending future applicable regulatory approvals.