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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 / K252320

510(k) cleared

SIMDA Abutments

Simda Co., Ltd. · Dec 18, 2025 · K252320

FDA cleared the SIMDA Abutments from Simda Co., Ltd. on Dec 18, 2025 under K252320, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 25, 2025. The decision came 146 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 Simda Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252320?

K252320 is the FDA 510(k) for SIMDA Abutments, submitted by Simda Co., Ltd.. FDA's decision date was Dec 18, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the SIMDA Abutments?

Simda Co., Ltd., based in Busan, is the applicant of record for K252320.

How long did the K252320 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Dec 18, 2025, 146 days later.

← All decisions in December 2025