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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 / November 2025 / K253513

510(k) cleared

MultiMatch Flow Chameleon AntiMicrobial Composite

Premier Dental Products Company · Nov 7, 2025 · K253513

FDA cleared the MultiMatch Flow Chameleon AntiMicrobial Composite from Premier Dental Products Company on Nov 7, 2025 under K253513, a traditional 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 Nov 6, 2025. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Premier Dental Products Company has one other decision in the tracker over the last 12 months: K260682 (Bond-PR Universal Adhesive).

Questions & Answers

What did FDA clear under K253513?

K253513 is the FDA 510(k) for MultiMatch Flow Chameleon AntiMicrobial Composite, submitted by Premier Dental Products Company. FDA's decision date was Nov 7, 2025, under product code EBF (Material, Tooth Shade, Resin).

Who makes the MultiMatch Flow Chameleon AntiMicrobial Composite?

Premier Dental Products Company, based in Plymouth Meeting, PA, is the applicant of record for K253513.

How long did the K253513 review take?

FDA received the submission on Nov 6, 2025 and issued its decision on Nov 7, 2025, 1 days later.

← All decisions in November 2025

Sources