Cleared Traditional

MAZIC Claro CAD and MAZIC Claro Press

K203672 · Vericom Co., Ltd. · Dental

Jul 2021

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K203672 is an FDA 510(k) clearance for the MAZIC Claro CAD and MAZIC Claro Press, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on July 1, 2021, 197 days after receiving the submission on December 16, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K203672 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2020
Decision Date	July 01, 2021
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF