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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 / May 2026 / K252731

510(k) cleared

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

Promimic AB · May 12, 2026 · K252731

FDA cleared the Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant from Promimic AB on May 12, 2026 under K252731, 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 Aug 28, 2025. The decision came 257 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 Promimic AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252731?

K252731 is the FDA 510(k) for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant, submitted by Promimic AB. FDA's decision date was May 12, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

Promimic AB, based in Mölndal, is the applicant of record for K252731.

How long did the K252731 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on May 12, 2026, 257 days later.

← All decisions in May 2026