Cleared Traditional

K200156 - Bright Low Flow
(FDA 510(k) Clearance)

K200156 · Genoss Co., Ltd. · Dental
Oct 2020
Decision
279d
Days
Class 2
Risk

K200156 is an FDA 510(k) clearance for the Bright Low Flow, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on October 27, 2020, 279 days after receiving the submission on January 22, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K200156 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2020
Decision Date October 27, 2020
Days to Decision 279 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690