Cleared Traditional

K142729 - Chi Lites Orthodontic Sapphire Bracket

K142729 is an FDA 510(k) clearance for Chi Lites Orthodontic Sapphire Bracket, manufactured by Progressive Technology, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K142729

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
Combination Product No
PCCP Authorized No
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.

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 45
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K142729.
BIJOU Orthodontic Ceramic Bracket
K152167 · World Bio Tech Co., Ltd. · May 2016
Avex CX2
K152779 · Opal Orthodontics by Ultradent Products · Nov 2015
Orthodontics Bracket
K150141 · Speed Dental Co., Ltd. · Oct 2015
TRUKLEAR BRACKET
K141104 · Ajw Technology Consultants, Inc. · Jun 2014
VAPOR CERAMIC BRACKET
K132368 · Orthodontic Design and Production, Inc. · Dec 2013
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
K131197 · Dental Morelli · Aug 2013