Cleared Traditional

U-Cem Premium & MAZIC Cem

K193260 · Vericom Co., Ltd. · Dental
Aug 2020
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K193260 is an FDA 510(k) clearance for the U-Cem Premium & MAZIC Cem, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on August 21, 2020, 269 days after receiving the submission on November 26, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K193260 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2019
Decision Date August 21, 2020
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275