Cleared Traditional

K142729 - Chi Lites Orthodontic Sapphire Bracket

K142729 is the FDA 510(k) clearance for Chi Lites Orthodontic Sapphire Bracket by Progressive Technology, Inc.. It is a Class 2 Dental device (product code NJM) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K142729 · Progressive Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
234d
Days
Class 2
Risk

K142729 is an FDA 510(k) clearance for the Chi Lites Orthodontic Sapphire Bracket. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Progressive Technology, Inc. (Rocklin, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 234 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 Progressive Technology, Inc. devices

Submission Details

510(k) Number K142729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date May 15, 2015
Days to Decision 234 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
107d slower than avg
Panel avg: 127d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K142729.
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
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Symetri Clear
K172845 · Ormco Corporation · Jan 2018
EMPOWER CLEAR
K122753 · American Orthodontics · Dec 2012
RADIANCE
K080749 · American Orthodontics · Aug 2008
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · Dentsply Intl. · Nov 2004