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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 / K251434

510(k) cleared

Healing Abutment System

Osstem Implant Co., Ltd. · Mar 4, 2026 · K251434

FDA cleared the Healing Abutment System from Osstem Implant Co., Ltd. on Mar 4, 2026 under K251434, 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 May 8, 2025. The decision came 300 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 Osstem Implant Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251434?

K251434 is the FDA 510(k) for Healing Abutment System, submitted by Osstem Implant Co., Ltd.. FDA's decision date was Mar 4, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Healing Abutment System?

Osstem Implant Co., Ltd., based in Busan, is the applicant of record for K251434.

How long did the K251434 review take?

FDA received the submission on May 8, 2025 and issued its decision on Mar 4, 2026, 300 days later.

← All decisions in March 2026