Cleared Traditional

U-Cem Premium & MAZIC Cem (K193260) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193260 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
269d
Days
Class 2
Risk

K193260 is an FDA 510(k) clearance for the U-Cem Premium & MAZIC Cem. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on August 21, 2020 after a review of 269 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Vericom Co., Ltd. devices

Submission Details

510(k) Number K193260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 127d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EMA Cement, Dental

All 135
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K193260.
Ceramir Restore QuikCap
K201937 · Doxa Dental AB · Nov 2020
Dual Cure Resin Cement
K201790 · Rizhao Huge Biomaterials Company, Ltd. · Sep 2020
Provicol QM Aesthetic
K201856 · Voco GmbH · Aug 2020
GC Fuji Triage EP
K193484 · GC America, Inc. · Jul 2020
TheraBase, TheraBase Ca
K192007 · Bisco, Inc. · Mar 2020
Surefil one Self-adhesive Composite Hybrid
K192530 · Dentsply Sirona · Jan 2020