Cleared Traditional

VENUS Bracket, ROSE Bracket (K201410) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 21
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K201410.
Ceramic Brackets Orthometric
K222847 · Orthometric - Industria E Comercio DE Produtos Medicos · May 2023
LightForce Orthodontic System
K222764 · Lightforce Orthodontics · Sep 2022
Vatech Clismile
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