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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 / February 2026 / K252286

510(k) cleared

BIORES Dental Implant System

Chengdu Besmile Medical Technology Co., Ltd. · Feb 2, 2026 · K252286

FDA cleared the BIORES Dental Implant System from Chengdu Besmile Medical Technology Co., Ltd. on Feb 2, 2026 under K252286, a abbreviated 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 Jul 23, 2025. The decision came 194 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 Chengdu Besmile Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252286?

K252286 is the FDA 510(k) for BIORES Dental Implant System, submitted by Chengdu Besmile Medical Technology Co., Ltd.. FDA's decision date was Feb 2, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the BIORES Dental Implant System?

Chengdu Besmile Medical Technology Co., Ltd., based in Chengdu, is the applicant of record for K252286.

How long did the K252286 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Feb 2, 2026, 194 days later.

← All decisions in February 2026