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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 / June 2026 / K253052

510(k) cleared

Fluoride Varnish (Type A,Type C)

Nagy Oral Technology Qinhuangdao Co., Ltd. · Jun 11, 2026 · K253052

FDA cleared the Fluoride Varnish (Type A,Type C) from Nagy Oral Technology Qinhuangdao Co., Ltd. on Jun 11, 2026 under K253052, a traditional 510(k). The device falls under product code LBH, Varnish, Cavity, regulated at 21 CFR 872.3260 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 22, 2025. The decision came 262 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 Nagy Oral Technology Qinhuangdao Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253052?

K253052 is the FDA 510(k) for Fluoride Varnish (Type A,Type C), submitted by Nagy Oral Technology Qinhuangdao Co., Ltd.. FDA's decision date was Jun 11, 2026, under product code LBH (Varnish, Cavity).

Who makes the Fluoride Varnish (Type A,Type C)?

Nagy Oral Technology Qinhuangdao Co., Ltd., based in Qinhuangdao, is the applicant of record for K253052.

How long did the K253052 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 11, 2026, 262 days later.

← All decisions in June 2026