Cleared Traditional

K171122 - CEREC Ortho Software

K171122 is an FDA 510(k) clearance for CEREC Ortho Software, manufactured by Dentsply Sirona. The device is a Class 2 Dental device with product code PNN cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K171122 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
269d
Days
Class 2
Risk

K171122 is an FDA 510(k) clearance for the CEREC Ortho Software. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on January 11, 2018 after a review of 269 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.

FDA 510(k) Submission Details - K171122

510(k) Number K171122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date January 11, 2018
Days to Decision 269 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
141d slower than avg
Panel avg: 128d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNN Device Classification - Class 2, Special Controls

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 34
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K171122.
Orchestrate 3D
K181112 · Orchestrate 3D · Nov 2018
Ortho System
K180941 · 3Shape A/S · Oct 2018
Ortho System
K171634 · 3Shape A/S · Jan 2018
ULab Systems Treatment Planning Software
K171295 · Ulab Systems, Inc. · Jan 2018
Ortho System
K163677 · 3Shape A/S · Apr 2017
GuideMia Ortho+
K162850 · Guidemia Technologies, LLC · Mar 2017