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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 / June 2026 / K252904

510(k) cleared

SIC Abutments including CAD/CAM Solutions

Sic Invent AG · Jun 3, 2026 · K252904

FDA cleared the SIC Abutments including CAD/CAM Solutions from Sic Invent AG on Jun 3, 2026 under K252904, 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 Sep 11, 2025. The decision came 265 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 Sic Invent AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252904?

K252904 is the FDA 510(k) for SIC Abutments including CAD/CAM Solutions, submitted by Sic Invent AG. FDA's decision date was Jun 3, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the SIC Abutments including CAD/CAM Solutions?

Sic Invent AG, based in Basel, is the applicant of record for K252904.

How long did the K252904 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Jun 3, 2026, 265 days later.

← All decisions in June 2026