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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 / November 2025 / K252582

510(k) cleared

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems

Prismatik Dentalcraft, Inc. · Nov 18, 2025 · K252582

FDA cleared the Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems from Prismatik Dentalcraft, Inc. on Nov 18, 2025 under K252582, 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 Aug 15, 2025. The decision came 95 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Prismatik Dentalcraft, Inc. has 2 other decisions in the tracker over the last 12 months: K262239 (Obsidian® Press Over Zirconia), K254283 (BruxZir® Shaded 16 PLUS).

Questions & Answers

What did FDA clear under K252582?

K252582 is the FDA 510(k) for Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems, submitted by Prismatik Dentalcraft, Inc.. FDA's decision date was Nov 18, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems?

Prismatik Dentalcraft, Inc., based in Irvine, CA, is the applicant of record for K252582.

How long did the K252582 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Nov 18, 2025, 95 days later.

← All decisions in November 2025

Sources