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 / March 2026 / K252031

510(k) cleared

Adin Long Dental Implant System

Adin Dental Implant Systems , Ltd. · Mar 23, 2026 · K252031

FDA cleared the Adin Long Dental Implant System from Adin Dental Implant Systems , Ltd. on Mar 23, 2026 under K252031, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 30, 2025. The decision came 266 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: K250178 (Adin Customized Abutments).

Questions & Answers

What did FDA clear under K252031?

K252031 is the FDA 510(k) for Adin Long Dental Implant System, submitted by Adin Dental Implant Systems , Ltd.. FDA's decision date was Mar 23, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the Adin Long Dental Implant System?

Adin Dental Implant Systems , Ltd., based in Afula, is the applicant of record for K252031.

How long did the K252031 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Mar 23, 2026, 266 days later.

← All decisions in March 2026

Sources