Cleared Traditional

K150392 - PROPEL device

K150392 is an FDA 510(k) clearance for PROPEL device, manufactured by Propel Orthodontics, LLC. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K150392 · Propel Orthodontics, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
212d
Days
Class 2
Risk

K150392 is an FDA 510(k) clearance for the PROPEL device. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Propel Orthodontics, LLC (Milpitas, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 212 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 Propel Orthodontics, LLC devices

FDA 510(k) Submission Details - K150392

510(k) Number K150392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date September 18, 2015
Days to Decision 212 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
85d slower than avg
Panel avg: 127d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZJ Device Classification - Class 2, Special Controls

Product Code DZJ Driver, Wire, And Bone Drill, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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

Coombs Medical Device Consulting
CRAIG J COOMBS

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.

Regulatory Peers - DZJ Driver, Wire, And Bone Drill, Manual

All 27
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K150392.
KLS Martin Individual Patient Solutions (IPS) Planning System
K182789 · KLS-Martin L.P. · Mar 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · KLS-Martin L.P. · Sep 2018
PROPEL Device
K172164 · Propel Orthodontics, LLC · Jan 2018
Dental Bone Cutting Instruments
K150796 · Synthes USA Products, LLC · Jun 2015
VSP SYSTEM
K133907 · Medical Modeling, Inc. · Jan 2014
VSP SYSTEM
K120956 · Medical Modeling, Inc. · Dec 2012