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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 / K252266

510(k) cleared

S.I.N. Dental Implant System

S.I.N. Implant System Ltda · Oct 17, 2025 · K252266

FDA cleared the S.I.N. Dental Implant System from S.I.N. Implant System Ltda on Oct 17, 2025 under K252266, 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 Jul 21, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

S.I.N. Implant System Ltda has 2 other decisions in the tracker over the last 12 months: K251129 (S.I.N. Tapered Pro Conical Zygoma Implant System), K251262 (S.I.N. Dental Implant System).

Questions & Answers

What did FDA clear under K252266?

K252266 is the FDA 510(k) for S.I.N. Dental Implant System, submitted by S.I.N. Implant System Ltda. FDA's decision date was Oct 17, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the S.I.N. Dental Implant System?

S.I.N. Implant System Ltda, based in São Paulo, is the applicant of record for K252266.

How long did the K252266 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Oct 17, 2025, 88 days later.

← All decisions in October 2025

Sources