Cleared Traditional

K180941 - Ortho System

K180941 is the FDA 510(k) clearance for Ortho System by 3Shape A/S. It is a Class 2 Dental device (product code PNN) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K180941 · 3Shape A/S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
203d
Days
Class 2
Risk

K180941 is an FDA 510(k) clearance for the Ortho System. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by 3Shape A/S (Copenhagen, DK). The FDA issued a Cleared decision on October 17, 2018 after a review of 203 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all 3Shape A/S devices

Submission Details

510(k) Number K180941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 127d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNN Orthodontic Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PNN Orthodontic Software

All 30
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K180941.
3Shape Splint Design
K191911 · 3Shape A/S · Nov 2019
OrthoAnalysis Software
K183695 · Inteware Co., Ltd. · Sep 2019
Orchestrate 3D
K181112 · Orchestrate 3D · Nov 2018
Ortho System
K171634 · 3Shape A/S · Jan 2018
CEREC Ortho Software
K171122 · Dentsply Sirona · Jan 2018
ULab Systems Treatment Planning Software
K171295 · Ulab Systems, Inc. · Jan 2018