Cleared Traditional

TN-Brush

K170596 · Genoss Co., Ltd. · Dental
Sep 2017
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K170596 is an FDA 510(k) clearance for the TN-Brush, a Scaler, Rotary (Class II — Special Controls, product code ELB), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 11, 2017, 195 days after receiving the submission on February 28, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4840.

Submission Details

510(k) Number K170596 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2017
Decision Date September 11, 2017
Days to Decision 195 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELB — Scaler, Rotary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4840