Cleared Traditional

V-varnish Premium

K160377 · Vericom Co., Ltd. · Dental
Dec 2016
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K160377 is an FDA 510(k) clearance for the V-varnish Premium, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on December 2, 2016, 296 days after receiving the submission on February 10, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K160377 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2016
Decision Date December 02, 2016
Days to Decision 296 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

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