Cleared Traditional

Symetri Clear

K172845 · Ormco Corporation · Dental
Jan 2018
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K172845 is an FDA 510(k) clearance for the Symetri Clear, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Ormco Corporation (Orange, US). The FDA issued a Cleared decision on January 31, 2018, 134 days after receiving the submission on September 19, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K172845 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2017
Decision Date January 31, 2018
Days to Decision 134 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.