Cleared Traditional

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System

K180404 · 3M Healthcare · Dental

Mar 2018

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K180404 is an FDA 510(k) clearance for the 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on March 16, 2018, 30 days after receiving the submission on February 14, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K180404 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2018
Decision Date	March 16, 2018
Days to Decision	30 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.