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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K252785

510(k) cleared

TopCEM Vigor SA Self-Adhesive Resin Cement

Rizhao Huge Biomaterials Company, Ltd. · Dec 12, 2025 · K252785

FDA cleared the TopCEM Vigor SA Self-Adhesive Resin Cement from Rizhao Huge Biomaterials Company, Ltd. on Dec 12, 2025 under K252785, a traditional 510(k). The device falls under product code EMA, Cement, Dental, regulated at 21 CFR 872.3275 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 2, 2025. The decision came 101 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Rizhao Huge Biomaterials Company, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252785?

K252785 is the FDA 510(k) for TopCEM Vigor SA Self-Adhesive Resin Cement, submitted by Rizhao Huge Biomaterials Company, Ltd.. FDA's decision date was Dec 12, 2025, under product code EMA (Cement, Dental).

Who makes the TopCEM Vigor SA Self-Adhesive Resin Cement?

Rizhao Huge Biomaterials Company, Ltd., based in Rizhao, is the applicant of record for K252785.

How long did the K252785 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Dec 12, 2025, 101 days later.

← All decisions in December 2025