Cleared Traditional

Carriere SLX 3D Clear

K173440 · Ortho Organizers, Inc. · Dental

Mar 2018

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K173440 is an FDA 510(k) clearance for the Carriere SLX 3D Clear, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 8, 2018, 122 days after receiving the submission on November 6, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K173440 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2017
Decision Date	March 08, 2018
Days to Decision	122 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.