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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 / March 2026 / K254245

510(k) cleared

ZAFIRA®

New Stetic, SA · Mar 3, 2026 · K254245

FDA cleared the ZAFIRA® from New Stetic, SA on Mar 3, 2026 under K254245, a traditional 510(k). The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 29, 2025. The decision came 64 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for New Stetic, SA in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254245?

K254245 is the FDA 510(k) for ZAFIRA®, submitted by New Stetic, SA. FDA's decision date was Mar 3, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the ZAFIRA®?

New Stetic, SA, based in Guarne, is the applicant of record for K254245.

How long did the K254245 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Mar 3, 2026, 64 days later.

← All decisions in March 2026