Cleared Traditional

Inspire ICE aka Inspire ICE Clear Brackets

K171844 · Ormco Corporation · Dental
Jul 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K171844 is an FDA 510(k) clearance for the Inspire ICE aka Inspire ICE Clear Brackets, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Ormco Corporation (Orange, US). The FDA issued a Cleared decision on July 18, 2017, 28 days after receiving the submission on June 20, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K171844 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2017
Decision Date July 18, 2017
Days to Decision 28 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.