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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 / October 2025 / K252165

510(k) cleared

ZIRCONOMER P

Shofu Dental Corporation · Oct 28, 2025 · K252165

FDA cleared the ZIRCONOMER P from Shofu Dental Corporation on Oct 28, 2025 under K252165, 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 Jul 10, 2025. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shofu Dental Corporation has one other decision in the tracker over the last 12 months: K252808 (GlasIonomer FX-LC).

Questions & Answers

What did FDA clear under K252165?

K252165 is the FDA 510(k) for ZIRCONOMER P, submitted by Shofu Dental Corporation. FDA's decision date was Oct 28, 2025, under product code EMA (Cement, Dental).

Who makes the ZIRCONOMER P?

Shofu Dental Corporation, based in San Marcos, CA, is the applicant of record for K252165.

How long did the K252165 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Oct 28, 2025, 110 days later.

← All decisions in October 2025

Sources