Align Technology gets FDA OK for Invisalign with mandibular advancement

Medical device company Align Technology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Invisalign treatment with mandibular advancement.

The new clear-aligner system simultaneously aligns teeth and repositions the lower jaw. The treatment replicates the action of functional appliances for class II correction through precision wings that hold the mandible in a forward position while simultaneously correcting malocclusion and crowding issues, according to Align Technology.

The treatment will be available in the U.S. beginning on November 19.

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