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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 / K250178

510(k) cleared

Adin Customized Abutments

Adin Dental Implant Systems , Ltd. · Oct 17, 2025 · K250178

FDA cleared the Adin Customized Abutments from Adin Dental Implant Systems , Ltd. on Oct 17, 2025 under K250178, 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 Jan 22, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Adin Dental Implant Systems , Ltd. has one other decision in the tracker over the last 12 months: K252031 (Adin Long Dental Implant System).

Questions & Answers

What did FDA clear under K250178?

K250178 is the FDA 510(k) for Adin Customized Abutments, submitted by Adin Dental Implant Systems , Ltd.. FDA's decision date was Oct 17, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Adin Customized Abutments?

Adin Dental Implant Systems , Ltd., based in Afula, is the applicant of record for K250178.

How long did the K250178 review take?

FDA received the submission on Jan 22, 2025 and issued its decision on Oct 17, 2025, 268 days later.

← All decisions in October 2025

Sources