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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 / August 2026 / K261456

510(k) cleared

Ruthinium Disc

Dental Manufacturing S.p.A. · Aug 5, 2026 · K261456

FDA cleared the Ruthinium Disc from Dental Manufacturing S.p.A. on Aug 5, 2026 under K261456, a traditional 510(k). The device falls under product code POW, Crown And Bridge, Long-Term Temporary, Resin, regulated at 21 CFR 872.3770 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 1, 2026. The decision came 96 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 Dental Manufacturing S.p.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261456?

K261456 is the FDA 510(k) for Ruthinium Disc, submitted by Dental Manufacturing S.p.A.. FDA's decision date was Aug 5, 2026, under product code POW (Crown And Bridge, Long-Term Temporary, Resin).

Who makes the Ruthinium Disc?

Dental Manufacturing S.p.A., based in Badia Polesine, is the applicant of record for K261456.

How long did the K261456 review take?

FDA received the submission on May 1, 2026 and issued its decision on Aug 5, 2026, 96 days later.

← All decisions in August 2026