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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 / K252197

510(k) cleared

Nobel Biocare S Series Implants

Nobel Biocare AB · Feb 18, 2026 · K252197

FDA cleared the Nobel Biocare S Series Implants from Nobel Biocare AB on Feb 18, 2026 under K252197, 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 Jul 14, 2025. The decision came 219 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nobel Biocare AB has 2 other decisions in the tracker over the last 12 months: K253999 (Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw), K252086 (DTX Studio Assist).

Questions & Answers

What did FDA clear under K252197?

K252197 is the FDA 510(k) for Nobel Biocare S Series Implants, submitted by Nobel Biocare AB. FDA's decision date was Feb 18, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the Nobel Biocare S Series Implants?

Nobel Biocare AB, based in Goteborg, is the applicant of record for K252197.

How long did the K252197 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Feb 18, 2026, 219 days later.

← All decisions in February 2026