Cleared Traditional

MAZIC Duro

K163346 · Vericom Co., Ltd. · Dental
Mar 2017
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K163346 is an FDA 510(k) clearance for the MAZIC Duro, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on March 17, 2017, 108 days after receiving the submission on November 29, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K163346 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2016
Decision Date March 17, 2017
Days to Decision 108 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