Cleared Special

ORTHODONTIC CERAMIC BRACKETS

K042178 · Dentsply Intl. · Dental
Aug 2004
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K042178 is an FDA 510(k) clearance for the ORTHODONTIC CERAMIC BRACKETS, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 30, 2004, 19 days after receiving the submission on August 11, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K042178 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2004
Decision Date August 30, 2004
Days to Decision 19 days
Submission Type Special
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.