Cleared Traditional

ORTHODONTIC CERAMIC BRACKETS

K123094 · Tomy, Inc. · Dental
Dec 2012
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K123094 is an FDA 510(k) clearance for the ORTHODONTIC CERAMIC BRACKETS, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Tomy, Inc. (Bradenton, US). The FDA issued a Cleared decision on December 13, 2012, 72 days after receiving the submission on October 2, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K123094 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2012
Decision Date December 13, 2012
Days to Decision 72 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.