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Align Technology, Inc. FDA Approvals

0 new drug approvals and 9 device clearances on file. Matched by name to ALGN.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Invisalign System510(k)Sep 25, 2026Dental
Invisalign® Palatal Expander System510(k)Oct 23, 2025Dental
Invisalign Specifix Attachment System510(k)Oct 9, 2025Dental
Invisalign System510(k)Aug 29, 2025Dental
Invisalign System510(k)Jun 18, 2024Dental
Invisalign Palatal Expander System510(k)Dec 15, 2023Dental
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks510(k)Sep 26, 2023Dental
Invisalign System, Pre-Formed Attachment System510(k)Dec 22, 2022Dental
Invisalign System510(k)Apr 7, 2022Dental

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