Cleared Traditional

K163467 - C-Line Orthodontic Ceramic Bracket

K163467 is an FDA 510(k) clearance for C-Line Orthodontic Ceramic Bracket, manufactured by Biocetec Co., Ltd.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K163467 · Biocetec Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
184d
Days
Class 2
Risk

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

Submitted by Biocetec Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on June 14, 2017 after a review of 184 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocetec Co., Ltd. devices

FDA 510(k) Submission Details - K163467

510(k) Number K163467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 128d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NJM Device Classification - Class 2, Special Controls

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Mtechgroup
DAVE KIM

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NJM Bracket, Ceramic, Orthodontic

All 57
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K163467.
Carriere SLX 3D Clear
K173440 · Ortho Organizers, Inc. · Mar 2018
Symetri Clear
K172845 · Ormco Corporation · Jan 2018
Inspire ICE aka Inspire ICE Clear Brackets
K171844 · Ormco Corporation · Jul 2017
Alpha Pure
K163117 · Koroad America · May 2017
CDB Self Ligating Bracket 8F
K160957 · Cdb Corporation · Sep 2016
ORTHODONTIC CERAMIC BRACKETS 1.1
K160615 · Tomy, Inc. · Aug 2016