Cleared Special

Ortho System (K171634) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K171634 · 3Shape A/S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
229d
Days
Class 2
Risk

K171634 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 January 17, 2018 after a review of 229 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3Shape A/S devices

Submission Details

510(k) Number K171634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 127d · This submission: 229d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K171634.
LingOral Dental Design System
K260419 · Hangzhou ChohoTech Co., Ltd. · May 2026
SureSmile Software
K253565 · Dentsply Sirona, Inc. · Mar 2026
SmileInspector
K252507 · Amv Consulting, LLC · Jan 2026
Celebrace Software
K253343 · Celebrace · Dec 2025
Laon Ortho
K250198 · Laon Medi, Inc. · Apr 2025
Progressive Orthodontics App
K241153 · Progressive Aligners, Inc. · Oct 2024