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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 / October 2025 / K251294

510(k) cleared

Bonafix Implant Abutments

Zentek Medical, LLC · Oct 15, 2025 · K251294

FDA cleared the Bonafix Implant Abutments from Zentek Medical, LLC on Oct 15, 2025 under K251294, 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 Apr 25, 2025. The decision came 173 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 Zentek Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251294?

K251294 is the FDA 510(k) for Bonafix Implant Abutments, submitted by Zentek Medical, LLC. FDA's decision date was Oct 15, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Bonafix Implant Abutments?

Zentek Medical, LLC, based in Manalapan, NJ, is the applicant of record for K251294.

How long did the K251294 review take?

FDA received the submission on Apr 25, 2025 and issued its decision on Oct 15, 2025, 173 days later.

← All decisions in October 2025