Cleared Traditional

K201410 - VENUS Bracket

K201410 is an FDA 510(k) clearance for VENUS Bracket, manufactured by Gni Co., Ltd.. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K201410 · Gni Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
288d
Days
Class 2
Risk

K201410 is an FDA 510(k) clearance for the VENUS Bracket, ROSE Bracket. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Gni Co., Ltd. (Hwaseong, KR). The FDA issued a Cleared decision on March 12, 2021 after a review of 288 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 Gni Co., Ltd. devices

FDA 510(k) Submission Details - K201410

510(k) Number K201410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2020
Decision Date March 12, 2021
Days to Decision 288 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
161d slower than avg
Panel avg: 127d · This submission: 288d
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

E & M
Sang Hwa Myung

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 25
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K201410.
Ceramic Brackets Orthometric
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LightForce Orthodontic System
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K220689 · Rayence Co., Ltd. · May 2022
Luce Ceramic Bracket
K201038 · Luce Castle Co., Ltd. · Oct 2020
LightForce Orthodontic System (LFO System)
K200148 · Lightforce Orthodontics · Feb 2020
ROSA Bracket
K182672 · Gni Co., Ltd. · Nov 2019