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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 / K251427

510(k) cleared

EK MULTI ANGLED 30 ABUTMENT

Hiossen, Inc. · Jan 29, 2026 · K251427

FDA cleared the EK MULTI ANGLED 30 ABUTMENT from Hiossen, Inc. on Jan 29, 2026 under K251427, 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 May 8, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hiossen, Inc. has one other decision in the tracker over the last 12 months: K253372 (ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments).

Questions & Answers

What did FDA clear under K251427?

K251427 is the FDA 510(k) for EK MULTI ANGLED 30 ABUTMENT, submitted by Hiossen, Inc.. FDA's decision date was Jan 29, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the EK MULTI ANGLED 30 ABUTMENT?

Hiossen, Inc., based in Fairless Hills, PA, is the applicant of record for K251427.

How long did the K251427 review take?

FDA received the submission on May 8, 2025 and issued its decision on Jan 29, 2026, 266 days later.

← All decisions in January 2026

Sources