Cleared Traditional

Bright High Flow (K200155) - FDA 510(k) Clearance

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

K200155 · Genoss Co., Ltd. · Dental device
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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

Submission Details

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.

Device Classification

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 291
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