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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 / December 2025 / K253312

510(k) cleared

OrangeCAD Med Abutments

Orangecad Med GmbH · Dec 23, 2025 · K253312

FDA cleared the OrangeCAD Med Abutments from Orangecad Med GmbH on Dec 23, 2025 under K253312, 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 Sep 30, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Orangecad Med GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253312?

K253312 is the FDA 510(k) for OrangeCAD Med Abutments, submitted by Orangecad Med GmbH. FDA's decision date was Dec 23, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the OrangeCAD Med Abutments?

Orangecad Med GmbH, based in Karlsruhe, is the applicant of record for K253312.

How long did the K253312 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 23, 2025, 84 days later.

← All decisions in December 2025