Cleared Traditional

iTero Element 5D

K193659 · Align Technology, Inc. · Dental
Mar 2020
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K193659 is an FDA 510(k) clearance for the iTero Element 5D, a Caries Detector, Laser Light, Transmission (Class II — Special Controls, product code NTK), submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on March 20, 2020, 81 days after receiving the submission on December 30, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K193659 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2019
Decision Date March 20, 2020
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NTK — Caries Detector, Laser Light, Transmission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745