FDA 510(k) Applications Submitted by ALIGN TECHNOLOGY, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K193659 12/30/2019 iTero Element 5D Align Technology, Inc.
K232233 07/27/2023 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks Align Technology, Inc.
K222894 09/23/2022 Invisalign System, Pre-Formed Attachment System Align Technology, Inc.
K143630 12/22/2014 Invisalign System ALIGN TECHNOLOGY, INC.
K220287 02/01/2022 Invisalign System Align Technology, Inc.
K181739 07/02/2018 Invisalign System with Mandibular Advancement Feature Align Technology, Inc.


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