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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 / June 2026 / K254145

510(k) cleared

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)

Smart Denture Conversions, LLC · Jun 11, 2026 · K254145

FDA cleared the Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) from Smart Denture Conversions, LLC on Jun 11, 2026 under K254145, a abbreviated 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 Dec 22, 2025. The decision came 171 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Smart Denture Conversions, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254145?

K254145 is the FDA 510(k) for Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut), submitted by Smart Denture Conversions, LLC. FDA's decision date was Jun 11, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)?

Smart Denture Conversions, LLC, based in Apex, NC, is the applicant of record for K254145.

How long did the K254145 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Jun 11, 2026, 171 days later.

← All decisions in June 2026