WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252808

510(k) cleared

GlasIonomer FX-LC

Shofu Dental Corporation · Dec 9, 2025 · K252808

FDA cleared the GlasIonomer FX-LC from Shofu Dental Corporation on Dec 9, 2025 under K252808, a traditional 510(k). The device falls under product code EMA, Cement, Dental, regulated at 21 CFR 872.3275 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 3, 2025. The decision came 97 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shofu Dental Corporation has one other decision in the tracker over the last 12 months: K252165 (ZIRCONOMER P).

Questions & Answers

What did FDA clear under K252808?

K252808 is the FDA 510(k) for GlasIonomer FX-LC, submitted by Shofu Dental Corporation. FDA's decision date was Dec 9, 2025, under product code EMA (Cement, Dental).

Who makes the GlasIonomer FX-LC?

Shofu Dental Corporation, based in San Marcos, CA, is the applicant of record for K252808.

How long did the K252808 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on Dec 9, 2025, 97 days later.

← All decisions in December 2025