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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K261295

510(k) cleared

MultiNeO Dental Implant System

Alpha Bio Tec , Ltd. · Oct 22, 2026 · K261295

FDA cleared the MultiNeO Dental Implant System from Alpha Bio Tec , Ltd. on Oct 22, 2026 under K261295, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 20, 2026. The decision came 185 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 Alpha Bio Tec , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261295?

K261295 is the FDA 510(k) for MultiNeO Dental Implant System, submitted by Alpha Bio Tec , Ltd.. FDA's decision date was Oct 22, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the MultiNeO Dental Implant System?

Alpha Bio Tec , Ltd., based in Modi'In, is the applicant of record for K261295.

How long did the K261295 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Oct 22, 2026, 185 days later.

← All decisions in October 2026