Cleared Special

NEO-CLIP ORTHODONTIC BRACKET ACCESSORY

K042905 · Dentsply Intl. · Dental

Nov 2004

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K042905 is an FDA 510(k) clearance for the NEO-CLIP ORTHODONTIC BRACKET ACCESSORY, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on November 4, 2004, 14 days after receiving the submission on October 21, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K042905 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2004
Decision Date	November 04, 2004
Days to Decision	14 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.