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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 / April 2026 / K260555

510(k) cleared

LOCATOR® Angled Abutment

Zest Anchors, LLC · Apr 9, 2026 · K260555

FDA cleared the LOCATOR® Angled Abutment from Zest Anchors, LLC on Apr 9, 2026 under K260555, a special 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 Feb 18, 2026. The decision came 50 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zest Anchors, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260555?

K260555 is the FDA 510(k) for LOCATOR® Angled Abutment, submitted by Zest Anchors, LLC. FDA's decision date was Apr 9, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the LOCATOR® Angled Abutment?

Zest Anchors, LLC, based in Carlsbad, CA, is the applicant of record for K260555.

How long did the K260555 review take?

FDA received the submission on Feb 18, 2026 and issued its decision on Apr 9, 2026, 50 days later.

← All decisions in April 2026