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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / September 2026 / K261327

510(k) cleared

Elos Accurate Hybrid Base

Elos Medtech Pinol A/S · Sep 30, 2026 · K261327

FDA cleared the Elos Accurate Hybrid Base from Elos Medtech Pinol A/S on Sep 30, 2026 under K261327, 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 Apr 22, 2026. The decision came 161 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Elos Medtech Pinol A/S has one other decision in the tracker over the last 12 months: K253774 (Elos Accurate® Denture Fixation System).

Questions & Answers

What did FDA clear under K261327?

K261327 is the FDA 510(k) for Elos Accurate Hybrid Base, submitted by Elos Medtech Pinol A/S. FDA's decision date was Sep 30, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Elos Accurate Hybrid Base?

Elos Medtech Pinol A/S, based in Goerloese, is the applicant of record for K261327.

How long did the K261327 review take?

FDA received the submission on Apr 22, 2026 and issued its decision on Sep 30, 2026, 161 days later.

← All decisions in September 2026

Sources