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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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