Cleared Traditional

CLICK-IT

K111234 · Tp Orthodontics, Inc. · Dental
May 2011
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K111234 is an FDA 510(k) clearance for the CLICK-IT, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on May 13, 2011, 11 days after receiving the submission on May 2, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K111234 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2011
Decision Date May 13, 2011
Days to Decision 11 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.