Cleared Traditional

Invisalign System

K143630 · Align Technology, Inc. · Dental
Nov 2015
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K143630 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 November 18, 2015, 331 days after receiving the submission on December 22, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K143630 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2014
Decision Date November 18, 2015
Days to Decision 331 days
Submission Type Traditional
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.