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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 / May 2026 / K253372

510(k) cleared

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments

Hiossen, Inc. · May 14, 2026 · K253372

FDA cleared the ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments from Hiossen, Inc. on May 14, 2026 under K253372, 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 226 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: K251427 (EK MULTI ANGLED 30 ABUTMENT).

Questions & Answers

What did FDA clear under K253372?

K253372 is the FDA 510(k) for ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments, submitted by Hiossen, Inc.. FDA's decision date was May 14, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments?

Hiossen, Inc., based in Fariless Hills, PA, is the applicant of record for K253372.

How long did the K253372 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on May 14, 2026, 226 days later.

← All decisions in May 2026

Sources