Cleared Traditional

Bright MTA Sealer Plus

K231480 · Genoss Co., Ltd. · Dental
Jul 2023
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K231480 is an FDA 510(k) clearance for the Bright MTA Sealer Plus, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on July 28, 2023, 67 days after receiving the submission on May 22, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K231480 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2023
Decision Date July 28, 2023
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820