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 / September 2025 / K251262

510(k) cleared

S.I.N. Dental Implant System

S.I.N. Implant System Ltda · Sep 26, 2025 · K251262

FDA cleared the S.I.N. Dental Implant System from S.I.N. Implant System Ltda on Sep 26, 2025 under K251262, 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 Apr 23, 2025. The decision came 156 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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), K252266 (S.I.N. Dental Implant System).

Questions & Answers

What did FDA clear under K251262?

K251262 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 Sep 26, 2025, under product code DZE (Implant, Endosseous, Root-Form).

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

S.I.N. Implant System Ltda, based in Sao Paulo, is the applicant of record for K251262.

How long did the K251262 review take?

FDA received the submission on Apr 23, 2025 and issued its decision on Sep 26, 2025, 156 days later.

← All decisions in September 2025

Sources