Cleared Special

K141104 - TRUKLEAR BRACKET

K141104 is an FDA 510(k) clearance for TRUKLEAR BRACKET, manufactured by Ajw Technology Consultants, Inc.. The device is a Class 2 Dental device with product code NJM cleared through the Special 510(k) pathway after a 57-day FDA review.

K141104 · Ajw Technology Consultants, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
57d
Days
Class 2
Risk

K141104 is an FDA 510(k) clearance for the TRUKLEAR BRACKET. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ajw Technology Consultants, Inc. (Apollo Beach, US). The FDA issued a Cleared decision on June 25, 2014 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141104

510(k) Number K141104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2014
Decision Date June 25, 2014
Days to Decision 57 days
Submission Type Special
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
71d faster than avg
Panel avg: 128d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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 58
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K141104.
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