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 / March 2026 / K253953

510(k) cleared

IPS e.max Zirconia

Ivoclar Vivadent, Inc. · Mar 10, 2026 · K253953

FDA cleared the IPS e.max Zirconia from Ivoclar Vivadent, Inc. on Mar 10, 2026 under K253953, a traditional 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 10, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Ivoclar Vivadent, Inc. has 2 other decisions in the tracker over the last 12 months: K261485 (Tetric plus Fill;Tetric plus Flow), K252450 (Adhese 2).

Questions & Answers

What did FDA clear under K253953?

K253953 is the FDA 510(k) for IPS e.max Zirconia, submitted by Ivoclar Vivadent, Inc.. FDA's decision date was Mar 10, 2026, under product code EIH (Powder, Porcelain).

Who makes the IPS e.max Zirconia?

Ivoclar Vivadent, Inc., based in Amherst, NY, is the applicant of record for K253953.

How long did the K253953 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Mar 10, 2026, 90 days later.

← All decisions in March 2026

Sources