Cleared Traditional

K181112 - Orchestrate 3D

K181112 is an FDA 510(k) clearance for Orchestrate 3D, manufactured by Orchestrate 3D. The device is a Class 2 Dental device with product code PNN cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K181112 · Orchestrate 3D · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
213d
Days
Class 2
Risk

K181112 is an FDA 510(k) clearance for the Orchestrate 3D. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Orchestrate 3D (Rialto, US). The FDA issued a Cleared decision on November 26, 2018 after a review of 213 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 Orchestrate 3D devices

FDA 510(k) Submission Details - K181112

510(k) Number K181112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2018
Decision Date November 26, 2018
Days to Decision 213 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
86d slower than avg
Panel avg: 127d · This submission: 213d
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 Consultant

Jcq Consulting
Bill Jacqmein

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.