Cleared Traditional

K160615 - ORTHODONTIC CERAMIC BRACKETS 1.1

K160615 is an FDA 510(k) clearance for ORTHODONTIC CERAMIC BRACKETS 1.1, manufactured by Tomy, Inc.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K160615 · Tomy, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
176d
Days
Class 2
Risk

K160615 is an FDA 510(k) clearance for the ORTHODONTIC CERAMIC BRACKETS 1.1. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Tomy, Inc. (Midoricho, Fuchu City, JP). The FDA issued a Cleared decision on August 26, 2016 after a review of 176 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 Tomy, Inc. devices

FDA 510(k) Submission Details - K160615

510(k) Number K160615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2016
Decision Date August 26, 2016
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
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 26
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K160615.
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K180404 · 3M Healthcare · Mar 2018
Carriere SLX 3D Clear
K173440 · Ortho Organizers, Inc. · Mar 2018
Symetri Clear
K172845 · Ormco Corporation · Jan 2018
EMPOWER CLEAR
K122753 · American Orthodontics · Dec 2012
DAMON 4CLEAR
K081415 · Ormco Corp. · Sep 2008
RADIANCE
K080749 · American Orthodontics · Aug 2008