Cleared Traditional

Ortho System

K163677 · 3Shape A/S · Dental
Apr 2017
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K163677 is an FDA 510(k) clearance for the Ortho System, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by 3Shape A/S (Copenhagen K, DK). The FDA issued a Cleared decision on April 20, 2017, 114 days after receiving the submission on December 27, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K163677 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2016
Decision Date April 20, 2017
Days to Decision 114 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PNN — Orthodontic Software
Device Class Class II — 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.