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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 / K252976

510(k) cleared

Park Dental Nylon MAD

Park Dental Research Corp. · Dec 18, 2025 · K252976

FDA cleared the Park Dental Nylon MAD from Park Dental Research Corp. on Dec 18, 2025 under K252976, a traditional 510(k). The device falls under product code LRK, Device, Anti-Snoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 17, 2025. The decision came 92 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 Park Dental Research Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252976?

K252976 is the FDA 510(k) for Park Dental Nylon MAD, submitted by Park Dental Research Corp.. FDA's decision date was Dec 18, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the Park Dental Nylon MAD?

Park Dental Research Corp., based in Ardmore, OK, is the applicant of record for K252976.

How long did the K252976 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Dec 18, 2025, 92 days later.

← All decisions in December 2025