Cleared Traditional

K150141 - Orthodontics Bracket

K150141 is an FDA 510(k) clearance for Orthodontics Bracket, manufactured by Speed Dental Co., Ltd.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K150141 · Speed Dental Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
274d
Days
Class 2
Risk

K150141 is an FDA 510(k) clearance for the Orthodontics Bracket. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Speed Dental Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on October 23, 2015 after a review of 274 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.

FDA 510(k) Submission Details - K150141

510(k) Number K150141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2015
Decision Date October 23, 2015
Days to Decision 274 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
146d slower than avg
Panel avg: 128d · This submission: 274d
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 Consultant

Onbix Corporation
Ho Dong Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K150141.
ORTHODONTIC CERAMIC BRACKETS 1.1
K160615 · Tomy, Inc. · Aug 2016
BIJOU Orthodontic Ceramic Bracket
K152167 · World Bio Tech Co., Ltd. · May 2016
Avex CX2
K152779 · Opal Orthodontics by Ultradent Products · Nov 2015
Chi Lites Orthodontic Sapphire Bracket
K142729 · Progressive Technology, Inc. · May 2015
TRUKLEAR BRACKET
K141104 · Ajw Technology Consultants, Inc. · Jun 2014
VAPOR CERAMIC BRACKET
K132368 · Orthodontic Design and Production, Inc. · Dec 2013