WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / June 2026 / K253776

510(k) cleared

Implantmed Plus II & Piezomed Plus II Module

W&H Dentalwerk Buermoos GmbH · Jun 18, 2026 · K253776

FDA cleared the Implantmed Plus II & Piezomed Plus II Module from W&H Dentalwerk Buermoos GmbH on Jun 18, 2026 under K253776, a traditional 510(k). The device falls under product code DZI, Drill, Bone, Powered, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Nov 26, 2025. The decision came 204 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 W&H Dentalwerk Buermoos GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253776?

K253776 is the FDA 510(k) for Implantmed Plus II & Piezomed Plus II Module, submitted by W&H Dentalwerk Buermoos GmbH. FDA's decision date was Jun 18, 2026, under product code DZI (Drill, Bone, Powered).

Who makes the Implantmed Plus II & Piezomed Plus II Module?

W&H Dentalwerk Buermoos GmbH, based in Buermoos, is the applicant of record for K253776.

How long did the K253776 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Jun 18, 2026, 204 days later.

← All decisions in June 2026