Cleared Traditional

K172164 - PROPEL Device

K172164 is the FDA 510(k) clearance for PROPEL Device by Propel Orthodontics, LLC. It is a Class 2 Dental device (product code DZJ) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K172164 · Propel Orthodontics, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
183d
Days
Class 2
Risk

K172164 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 January 17, 2018 after a review of 183 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

Submission Details

510(k) Number K172164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2017
Decision Date January 17, 2018
Days to Decision 183 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
56d slower than avg
Panel avg: 127d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 21
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K172164.
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KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · KLS-Martin L.P. · Sep 2018
Dental Bone Cutting Instruments
K150796 · Synthes USA Products, LLC · Jun 2015
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K040369 · Stryker Instruments · Apr 2004
SURGICAL CUTTING BURS
K943540 · Stryker Corp. · Nov 1994