Cleared Traditional

ORTHODONTIC CERAMIC BRACKETS 1.1

K160615 · Tomy, Inc. · Dental

Aug 2016

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K160615 is an FDA 510(k) clearance for the ORTHODONTIC CERAMIC BRACKETS 1.1, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Tomy, Inc. (Midoricho, Fuchu City, JP). The FDA issued a Cleared decision on August 26, 2016, 176 days after receiving the submission on March 3, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K160615 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NJM — Bracket, Ceramic, Orthodontic
Device Class	Class II — 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.