Cleared Traditional

K262196 - Invisalign System

K262196 is an FDA 510(k) clearance for Invisalign System, manufactured by Align Technology, Inc.. The device is a Class 2 Dental device with product code PNN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K262196 · Align Technology, Inc. · Dental device
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Sep 2026
Decision
88d
Days
Class 2
Risk

K262196 is an FDA 510(k) clearance for the Invisalign System. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on September 25, 2026 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Align Technology, Inc. devices

FDA 510(k) Submission Details - K262196

510(k) Number K262196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2026
Decision Date September 25, 2026
Days to Decision 88 days
Submission Type Traditional
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
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNN Device Classification - Class 2, Special Controls

Product Code PNN Orthodontic Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.
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 - PNN Orthodontic Software

All 34
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K262196.
LingOral Dental Design System
K260419 · Hangzhou ChohoTech Co., Ltd. · May 2026
SureSmile Software
K253565 · Dentsply Sirona, Inc. · Mar 2026
SmileInspector
K252507 · Amv Consulting, LLC · Jan 2026
Celebrace Software
K253343 · Celebrace · Dec 2025
Laon Ortho
K250198 · Laon Medi, Inc. · Apr 2025
Progressive Orthodontics App
K241153 · Progressive Aligners, Inc. · Oct 2024