Cleared Traditional

K173440 - Carriere SLX 3D Clear

K173440 is an FDA 510(k) clearance for Carriere SLX 3D Clear, manufactured by Ortho Organizers, Inc.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K173440 · Ortho Organizers, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
122d
Days
Class 2
Risk

K173440 is an FDA 510(k) clearance for the Carriere SLX 3D Clear. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 8, 2018 after a review of 122 days - within the typical 510(k) review window.

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 Ortho Organizers, Inc. devices

FDA 510(k) Submission Details - K173440

510(k) Number K173440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2017
Decision Date March 08, 2018
Days to Decision 122 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
5d faster than avg
Panel avg: 127d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NJM Device Classification - Class 2, Special Controls

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.
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 - NJM Bracket, Ceramic, Orthodontic

All 25
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K173440.
Signature Orthodontic System
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Signature Orthodontic System
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K180404 · 3M Healthcare · Mar 2018
Symetri Clear
K172845 · Ormco Corporation · Jan 2018
EMPOWER CLEAR
K122753 · American Orthodontics · Dec 2012
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K081415 · Ormco Corp. · Sep 2008