Cleared Traditional

Ortho System

K180941 · 3Shape A/S · Dental
Oct 2018
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K180941 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, DK). The FDA issued a Cleared decision on October 17, 2018, 203 days after receiving the submission on March 28, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K180941 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2018
Decision Date October 17, 2018
Days to Decision 203 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.