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 / November 2025 / K251129

510(k) cleared

S.I.N. Tapered Pro Conical Zygoma Implant System

S.I.N. Implant System Ltda · Nov 7, 2025 · K251129

FDA cleared the S.I.N. Tapered Pro Conical Zygoma Implant System from S.I.N. Implant System Ltda on Nov 7, 2025 under K251129, 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 11, 2025. The decision came 210 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: K252266 (S.I.N. Dental Implant System), K251262 (S.I.N. Dental Implant System).

Questions & Answers

What did FDA clear under K251129?

K251129 is the FDA 510(k) for S.I.N. Tapered Pro Conical Zygoma Implant System, submitted by S.I.N. Implant System Ltda. FDA's decision date was Nov 7, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the S.I.N. Tapered Pro Conical Zygoma Implant System?

S.I.N. Implant System Ltda, based in São Paulo, is the applicant of record for K251129.

How long did the K251129 review take?

FDA received the submission on Apr 11, 2025 and issued its decision on Nov 7, 2025, 210 days later.

← All decisions in November 2025

Sources