Cleared Traditional

K162609 - ClearPath Aligner

K162609 is an FDA 510(k) clearance for ClearPath Aligner, manufactured by Clearpath Orthodontics, Ltd.. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K162609 · Clearpath Orthodontics, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
290d
Days
Class 2
Risk

K162609 is an FDA 510(k) clearance for the ClearPath Aligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Clearpath Orthodontics, Ltd. (Johar Town, PK). The FDA issued a Cleared decision on July 6, 2017 after a review of 290 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 Clearpath Orthodontics, Ltd. devices

FDA 510(k) Submission Details - K162609

510(k) Number K162609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date July 06, 2017
Days to Decision 290 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 127d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NXC Device Classification - Class 2, Special Controls

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
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 - NXC Aligner, Sequential

All 128
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K162609.
Blue Sky Bio Aligner
K180107 · Blue Sky Bio, LLC · Feb 2018
Angel Align System
K171674 · Smile Development Corp · Jan 2018
Sureclear aligners
K171860 · Emergo Global Consulting, LLC · Jan 2018
MTM Clear Aligner
K163155 · Dentsply Sirona · Feb 2017
MTM(R) CLEAR ALIGNER
K132145 · Dentsply International, Inc. · Oct 2013
MTM CLEAR ALIGNER IN-OFFICE
K123925 · Dentsply International, Inc. · May 2013