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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 / K251605

510(k) cleared

DIMPLO Implant System

DIMPLO, Ltd. · Dec 22, 2025 · K251605

FDA cleared the DIMPLO Implant System from DIMPLO, Ltd. on Dec 22, 2025 under K251605, 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 May 27, 2025. The decision came 209 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 DIMPLO, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251605?

K251605 is the FDA 510(k) for DIMPLO Implant System, submitted by DIMPLO, Ltd.. FDA's decision date was Dec 22, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the DIMPLO Implant System?

DIMPLO, Ltd., based in Busan, is the applicant of record for K251605.

How long did the K251605 review take?

FDA received the submission on May 27, 2025 and issued its decision on Dec 22, 2025, 209 days later.

← All decisions in December 2025