Cleared Traditional

K200155 - Bright High Flow

K200155 is an FDA 510(k) clearance for Bright High Flow, manufactured by Genoss Co., Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K200155 · Genoss Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
313d
Days
Class 2
Risk

K200155 is an FDA 510(k) clearance for the Bright High Flow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on November 30, 2020 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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. Elevated predicate reliance profile. 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 Genoss Co., Ltd. devices

FDA 510(k) Submission Details - K200155

510(k) Number K200155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2020
Decision Date November 30, 2020
Days to Decision 313 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
186d slower than avg
Panel avg: 127d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 Peers - EBF Material, Tooth Shade, Resin

All 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K200155.
Shofu Block HC Hard
K200470 · Shofu Dental Corporation · Feb 2021
Omnichroma Flow Bulk
K203598 · Tokuyama Dental Corporation · Feb 2021
Opallis, Opallis Flow
K201707 · Dentscare Ltda · Dec 2020
Bright Low Flow
K200156 · Genoss Co., Ltd. · Oct 2020
Transcend
K201795 · Ultradent Product, Inc. · Sep 2020
Omnichroma Flow
K193537 · Tokuyama Dental Corporation · Aug 2020