Cleared Special

Ortho System

K171634 · 3Shape A/S · Dental
Jan 2018
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K171634 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 January 17, 2018, 229 days after receiving the submission on June 2, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K171634 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2017
Decision Date January 17, 2018
Days to Decision 229 days
Submission Type Special
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.