Cleared Traditional

Bright Bond Universal

K200153 · Genoss Co., Ltd. · Dental
Oct 2020
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K200153 is an FDA 510(k) clearance for the Bright Bond Universal, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on October 28, 2020, 280 days after receiving the submission on January 22, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K200153 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2020
Decision Date October 28, 2020
Days to Decision 280 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200