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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 / March 2026 / K260830

510(k) cleared

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)

Sangi Co., Ltd. · Mar 18, 2026 · K260830

FDA cleared the APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) from Sangi Co., Ltd. on Mar 18, 2026 under K260830, a traditional 510(k) reviewed through the Third Party Review Program. 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 Mar 13, 2026. The decision came 5 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Sangi Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260830?

K260830 is the FDA 510(k) for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste), submitted by Sangi Co., Ltd.. FDA's decision date was Mar 18, 2026, under product code LBH (Varnish, Cavity).

Who makes the APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)?

Sangi Co., Ltd., based in Tokyo, is the applicant of record for K260830.

How long did the K260830 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on Mar 18, 2026, 5 days later.

← All decisions in March 2026