Invisalign System— 510(k) K262196

Name: FDA 510(k) clearance K262196
Creator: U.S. Food and Drug Administration
Published: 2026-09-25

Substantially Equivalent

Align Technology, Inc.

FDA 510(k) clearance K262196 for Invisalign System, Substantially Equivalent on 2026-09-25. Applicant: Align Technology, Inc.. Device class: 2.

Summary

This clearance is for the Invisalign System from Align Technology, Inc., filed under PNN, orthodontic software. The record doesn't say which parts of the system this submission covers.

Class II, 21 CFR 872.5470. The Dental panel reviewed it as a Traditional 510(k).

Align filed from San Jose, California. Review took 88 days (June 29 to September 25, 2026).

Clearance details

Applicant: Align Technology, Inc.
Product code: Product code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2026-06-29
Decision date: 2026-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNN

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K262378 — Dr.AlignNavi2026-10-07
K260419 — LingOral Dental Design System2026-05-08
K253565 — SureSmile Software2026-03-04
K252507 — SmileInspector2026-01-07
K253343 — Celebrace Software2025-12-29

More clearances from Align Technology, Inc.

view all

K252931 — Invisalign® Palatal Expander System2025-10-23
K252870 — Invisalign Specifix Attachment System2025-10-09
K252380 — Invisalign System2025-08-29
K241412 — Invisalign System2024-06-18
K232887 — Invisalign Palatal Expander System2023-12-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.