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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 / September 2025 / K253236

510(k) cleared

G-BLOCK

Graphenano Dental S.L. · Sep 29, 2025 · K253236

FDA cleared the G-BLOCK from Graphenano Dental S.L. on Sep 29, 2025 under K253236, a abbreviated 510(k) reviewed through the Third Party Review Program. 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 Sep 29, 2025. The decision came 0 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Graphenano Dental S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253236?

K253236 is the FDA 510(k) for G-BLOCK, submitted by Graphenano Dental S.L.. FDA's decision date was Sep 29, 2025, under product code EBF (Material, Tooth Shade, Resin).

Who makes the G-BLOCK?

Graphenano Dental S.L., based in Valencia, is the applicant of record for K253236.

How long did the K253236 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Sep 29, 2025, 0 days later.

← All decisions in September 2025