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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 / K252789

510(k) cleared

Glass Ceramic

Shenzhen Xiangtong Co., Ltd. · Dec 8, 2025 · K252789

FDA cleared the Glass Ceramic from Shenzhen Xiangtong Co., Ltd. on Dec 8, 2025 under K252789, a abbreviated 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 2, 2025. The decision came 97 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 Shenzhen Xiangtong Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252789?

K252789 is the FDA 510(k) for Glass Ceramic, submitted by Shenzhen Xiangtong Co., Ltd.. FDA's decision date was Dec 8, 2025, under product code EIH (Powder, Porcelain).

Who makes the Glass Ceramic?

Shenzhen Xiangtong Co., Ltd., based in Dongguan, is the applicant of record for K252789.

How long did the K252789 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Dec 8, 2025, 97 days later.

← All decisions in December 2025