Cleared Traditional

TopCEM Vigor SA Self-Adhesive Resin Cement

K252785 · Rizhao Huge Biomaterials Company, Ltd. · Dental
Dec 2025
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K252785 is an FDA 510(k) clearance for the TopCEM Vigor SA Self-Adhesive Resin 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 December 12, 2025, 101 days after receiving the submission on September 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K252785 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2025
Decision Date December 12, 2025
Days to Decision 101 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