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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 / December 2025 / K253758

510(k) cleared

Dental Cone; Dental Sponge

Medizin Produkte Neustadt GmbH (Mpn) · Dec 18, 2025 · K253758

FDA cleared the Dental Cone; Dental Sponge from Medizin Produkte Neustadt GmbH (Mpn) on Dec 18, 2025 under K253758, a special 510(k). The device falls under product code OLR, Oral Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 25, 2025. The decision came 23 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Medizin Produkte Neustadt GmbH (Mpn) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253758?

K253758 is the FDA 510(k) for Dental Cone; Dental Sponge, submitted by Medizin Produkte Neustadt GmbH (Mpn). FDA's decision date was Dec 18, 2025, under product code OLR (Oral Wound Dressing).

Who makes the Dental Cone; Dental Sponge?

Medizin Produkte Neustadt GmbH (Mpn), based in Saal/Donau Bavaria, is the applicant of record for K253758.

How long did the K253758 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Dec 18, 2025, 23 days later.

← All decisions in December 2025