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Align Technology, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262196 Invisalign SystemPNN2026-09-25 View
510(k) K252931 Invisalign® Palatal Expander SystemNXC2025-10-23 View
510(k) K252870 Invisalign Specifix Attachment SystemNXC2025-10-09 View
510(k) K252380 Invisalign SystemNXC2025-08-29 View
510(k) K241412 Invisalign SystemNXC2024-06-18 View
510(k) K232887 Invisalign Palatal Expander SystemNXC2023-12-15 View
510(k) K232233 Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXC2023-09-26 View
510(k) K222894 Invisalign System, Pre-Formed Attachment SystemNXC2022-12-22 View
510(k) K220287 Invisalign SystemNXC2022-04-07 View
510(k) K193659 iTero Element 5DNTK2020-03-20 View
510(k) K181739 Invisalign System with Mandibular Advancement FeatureNXC2018-10-26 View
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