Cleared Traditional

EMPOWER CLEAR

K122753 · American Orthodontics · Dental
Dec 2012
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K122753 is an FDA 510(k) clearance for the EMPOWER CLEAR, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on December 14, 2012, 98 days after receiving the submission on September 7, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K122753 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2012
Decision Date December 14, 2012
Days to Decision 98 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.