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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 / May 2026 / K260376

510(k) cleared

Denture Base

Shandong Huge Dental Material Corporation · May 6, 2026 · K260376

FDA cleared the Denture Base from Shandong Huge Dental Material Corporation on May 6, 2026 under K260376, a traditional 510(k). The device falls under product code EBI, Resin, Denture, Relining, Repairing, Rebasing, regulated at 21 CFR 872.3760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Feb 5, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Shandong Huge Dental Material Corporation has one other decision in the tracker over the last 12 months: K260067 (Eternal Art Porcelain Powders).

Questions & Answers

What did FDA clear under K260376?

K260376 is the FDA 510(k) for Denture Base, submitted by Shandong Huge Dental Material Corporation. FDA's decision date was May 6, 2026, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the Denture Base?

Shandong Huge Dental Material Corporation, based in Rizhao City, is the applicant of record for K260376.

How long did the K260376 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on May 6, 2026, 90 days later.

← All decisions in May 2026

Sources