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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 / January 2026 / K251701

510(k) cleared

Star E900 Electric System

Dentalez, Inc., Stardental Division · Jan 12, 2026 · K251701

FDA cleared the Star E900 Electric System from Dentalez, Inc., Stardental Division on Jan 12, 2026 under K251701, a traditional 510(k). The device falls under product code EBW, Controller, Foot, Handpiece And Cord, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on Jun 2, 2025. The decision came 224 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 Dentalez, Inc., Stardental Division in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251701?

K251701 is the FDA 510(k) for Star E900 Electric System, submitted by Dentalez, Inc., Stardental Division. FDA's decision date was Jan 12, 2026, under product code EBW (Controller, Foot, Handpiece And Cord).

Who makes the Star E900 Electric System?

Dentalez, Inc., Stardental Division, based in Lancaster, PA, is the applicant of record for K251701.

How long did the K251701 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Jan 12, 2026, 224 days later.

← All decisions in January 2026