
Align Technology, Inc.
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Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is an FDA 510(k)-cleared medical device (K232233) manufactured by Align Technology, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2023. Regulation: 8.