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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 / K260061

510(k) cleared

BioHorizons CEREC Compatible Ti-Bases

BioHorizons Implant Systems, Inc. · Jun 26, 2026 · K260061

FDA cleared the BioHorizons CEREC Compatible Ti-Bases from BioHorizons Implant Systems, Inc. on Jun 26, 2026 under K260061, 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 Jan 8, 2026. The decision came 169 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 BioHorizons Implant Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260061?

K260061 is the FDA 510(k) for BioHorizons CEREC Compatible Ti-Bases, submitted by BioHorizons Implant Systems, Inc.. FDA's decision date was Jun 26, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the BioHorizons CEREC Compatible Ti-Bases?

BioHorizons Implant Systems, Inc., based in Birmingham, AL, is the applicant of record for K260061.

How long did the K260061 review take?

FDA received the submission on Jan 8, 2026 and issued its decision on Jun 26, 2026, 169 days later.

← All decisions in June 2026