Cleared Special

Invisalign System (K220287) - FDA 510(k) Clearance

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

K220287 · Align Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
65d
Days
Class 2
Risk

K220287 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 April 7, 2022 after a review of 65 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 K220287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2022
Decision Date April 07, 2022
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 K220287.
Custom-made Invisible Aligners
K203624 · Zhejiang Yinchili Medical Technology Co., Ltd. · Jun 2022
LuxCreo Clear Aligner System
K212680 · LuxCreo, Inc. · May 2022
DailyMate Orthodontic Aligner System
K212803 · 3D Global Biotech, Inc. · May 2022
K Clear
K220726 · Kline Europe GmbH · Mar 2022
uLab Systems Dental Aligner Kit
K211510 · Ulab Systems, Inc. · Feb 2022
Redline
K213297 · Johns Dental Laboratories · Feb 2022