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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 / January 2026 / K254283

510(k) cleared

BruxZir® Shaded 16 PLUS

Prismatik Dentalcraft, Inc. · Jan 30, 2026 · K254283

FDA cleared the BruxZir® Shaded 16 PLUS from Prismatik Dentalcraft, Inc. on Jan 30, 2026 under K254283, 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 Dec 31, 2025. The decision came 30 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: K262239 (Obsidian® Press Over Zirconia), K252582 (Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems).

Questions & Answers

What did FDA clear under K254283?

K254283 is the FDA 510(k) for BruxZir® Shaded 16 PLUS, submitted by Prismatik Dentalcraft, Inc.. FDA's decision date was Jan 30, 2026, under product code EIH (Powder, Porcelain).

Who makes the BruxZir® Shaded 16 PLUS?

Prismatik Dentalcraft, Inc., based in Irvine, CA, is the applicant of record for K254283.

How long did the K254283 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Jan 30, 2026, 30 days later.

← All decisions in January 2026

Sources