Cleared Traditional

K163467 - C-Line Orthodontic Ceramic Bracket
(FDA 510(k) Clearance)

K163467 · Biocetec Co., Ltd. · Dental
Jun 2017
Decision
184d
Days
Class 2
Risk

K163467 is an FDA 510(k) clearance for the C-Line Orthodontic Ceramic Bracket. This device is classified as a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM).

Submitted by Biocetec Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on June 14, 2017, 184 days after receiving the submission on December 12, 2016.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. 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..

Submission Details

510(k) Number K163467 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2016
Decision Date June 14, 2017
Days to Decision 184 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.