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THE TAPE

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 / September 2025 / K251148

510(k) cleared

JDEvolution Plus L and JDEvolution Plus LE

Jdentalcare Srl · Sep 25, 2025 · K251148

FDA cleared the JDEvolution Plus L and JDEvolution Plus LE from Jdentalcare Srl on Sep 25, 2025 under K251148, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 14, 2025. The decision came 164 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 Jdentalcare Srl in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251148?

K251148 is the FDA 510(k) for JDEvolution Plus L and JDEvolution Plus LE, submitted by Jdentalcare Srl. FDA's decision date was Sep 25, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the JDEvolution Plus L and JDEvolution Plus LE?

Jdentalcare Srl, based in Modena, is the applicant of record for K251148.

How long did the K251148 review take?

FDA received the submission on Apr 14, 2025 and issued its decision on Sep 25, 2025, 164 days later.

← All decisions in September 2025