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 / July 2026 / K262239

510(k) cleared

Obsidian® Press Over Zirconia

Prismatik Dentalcraft, Inc. · Jul 30, 2026 · K262239

FDA cleared the Obsidian® Press Over Zirconia from Prismatik Dentalcraft, Inc. on Jul 30, 2026 under K262239, a special 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 Jul 1, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Prismatik Dentalcraft, Inc. has 2 other decisions in the tracker over the last 12 months: K254283 (BruxZir® Shaded 16 PLUS), K252582 (Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems).

Questions & Answers

What did FDA clear under K262239?

K262239 is the FDA 510(k) for Obsidian® Press Over Zirconia, submitted by Prismatik Dentalcraft, Inc.. FDA's decision date was Jul 30, 2026, under product code EIH (Powder, Porcelain).

Who makes the Obsidian® Press Over Zirconia?

Prismatik Dentalcraft, Inc., based in Irvine, CA, is the applicant of record for K262239.

How long did the K262239 review take?

FDA received the submission on Jul 1, 2026 and issued its decision on Jul 30, 2026, 29 days later.

← All decisions in July 2026

Sources