Cleared Special

Invisalign System

K241412 · Align Technology, Inc. · Dental

Jun 2024

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K241412 is an FDA 510(k) clearance for the Invisalign System, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on June 18, 2024, 32 days after receiving the submission on May 17, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K241412 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NXC — Aligner, Sequential
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.5470
Definition	The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.