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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 / April 2026 / K254091

510(k) cleared

GLOSSY COAT (15ML)

YAMAHACHI DENTAL MFG., Co. · Apr 6, 2026 · K254091

FDA cleared the GLOSSY COAT (15ML) from YAMAHACHI DENTAL MFG., Co. on Apr 6, 2026 under K254091, a traditional 510(k). The device falls under product code EBD, Coating, Filling Material, Resin, regulated at 21 CFR 872.3310 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 19, 2025. The decision came 108 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 YAMAHACHI DENTAL MFG., Co. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254091?

K254091 is the FDA 510(k) for GLOSSY COAT (15ML), submitted by YAMAHACHI DENTAL MFG., Co.. FDA's decision date was Apr 6, 2026, under product code EBD (Coating, Filling Material, Resin).

Who makes the GLOSSY COAT (15ML)?

YAMAHACHI DENTAL MFG., Co., based in Gamagori, is the applicant of record for K254091.

How long did the K254091 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Apr 6, 2026, 108 days later.

← All decisions in April 2026