Cleared Special

Invisalign System (K241412) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241412 · Align Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
32d
Days
Class 2
Risk

K241412 is an FDA 510(k) clearance for the Invisalign System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on June 18, 2024 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Align Technology, Inc. devices

Submission Details

510(k) Number K241412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2024
Decision Date June 18, 2024
Days to Decision 32 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K241412.
Illusion Aligner Pro: Illusion Aligner FLX
K233356 · Laxmi Dental Export Pvt., Ltd. · Aug 2024
Clear Moves Aligner
K241137 · Clear Moves Aligners · Aug 2024
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K241187 · Alien Milling Technologies · Jul 2024
DigiLine Direct Print Aligner System
K233935 · Park Dental Research Corporation · Apr 2024
Clear Moves Aligners
K240038 · Space Maintainers Laboratories (Sml) · Apr 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653 · Blue Sky Bio, LLC · Apr 2024