U-Cem Premium & MAZIC Cem

Cement, Dental

Vericom Co., Ltd.

The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for U-cem Premium & Mazic Cem.

Pre-market Notification Details

Device IDK193260
510k NumberK193260
Device Name:U-Cem Premium & MAZIC Cem
ClassificationCement, Dental
Applicant Vericom Co., Ltd. 48, Toegyegongdan 1-Gil, Chuncheon-si,  KR 200-944
ContactYun Ki Kim
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc 1150 Roosevelt, STE 200 Irvine,  CA  92620
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-08-21

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