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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 / October 2025 / K252944

510(k) cleared

LOCATOR® Angled Abutment

Zest Anchors, LLC · Oct 15, 2025 · K252944

FDA cleared the LOCATOR® Angled Abutment from Zest Anchors, LLC on Oct 15, 2025 under K252944, 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 Sep 15, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Zest Anchors, LLC has one other decision in the tracker over the last 12 months: K260555 (LOCATOR® Angled Abutment).

Questions & Answers

What did FDA clear under K252944?

K252944 is the FDA 510(k) for LOCATOR® Angled Abutment, submitted by Zest Anchors, LLC. FDA's decision date was Oct 15, 2025, 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 K252944.

How long did the K252944 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Oct 15, 2025, 30 days later.

← All decisions in October 2025

Sources