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Align Technology, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories2
Latest Approval2025-10-23
TypeNumberDevice NameCodeDate
510(k) K252931 Invisalign® Palatal Expander System NXC 2025-10-23 View
510(k) K252870 Invisalign Specifix Attachment System NXC 2025-10-09 View
510(k) K252380 Invisalign System NXC 2025-08-29 View
510(k) K241412 Invisalign System NXC 2024-06-18 View
510(k) K232887 Invisalign Palatal Expander System NXC 2023-12-15 View
510(k) K232233 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks NXC 2023-09-26 View
510(k) K222894 Invisalign System, Pre-Formed Attachment System NXC 2022-12-22 View
510(k) K220287 Invisalign System NXC 2022-04-07 View
510(k) K193659 iTero Element 5D NTK 2020-03-20 View
510(k) K181739 Invisalign System with Mandibular Advancement Feature NXC 2018-10-26 View
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