Cleared Traditional

TopCEM-Veneer Light Cure Veneer Cement

K241204 · Rizhao Huge Biomaterials Company, Ltd. · Dental
Jun 2024
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K241204 is an FDA 510(k) clearance for the TopCEM-Veneer Light Cure Veneer Cement, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on June 28, 2024, 59 days after receiving the submission on April 30, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K241204 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2024
Decision Date June 28, 2024
Days to Decision 59 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