Cleared Traditional

3Shape Splint Design

K191911 · 3Shape A/S · Dental
Nov 2019
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K191911 is an FDA 510(k) clearance for the 3Shape Splint Design, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by 3Shape A/S (Copenhagen, DK). The FDA issued a Cleared decision on November 27, 2019, 133 days after receiving the submission on July 17, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K191911 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2019
Decision Date November 27, 2019
Days to Decision 133 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.