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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 / July 2026 / K253655

510(k) cleared

Angled Screwdriver MED (M-SD090)

W&H Dentalwerk Bürmoos GmbH · Jul 31, 2026 · K253655

FDA cleared the Angled Screwdriver MED (M-SD090) from W&H Dentalwerk Bürmoos GmbH on Jul 31, 2026 under K253655, 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 20, 2025. The decision came 253 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 Bürmoos GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253655?

K253655 is the FDA 510(k) for Angled Screwdriver MED (M-SD090), submitted by W&H Dentalwerk Bürmoos GmbH. FDA's decision date was Jul 31, 2026, under product code DZI (Drill, Bone, Powered).

Who makes the Angled Screwdriver MED (M-SD090)?

W&H Dentalwerk Bürmoos GmbH, based in Buermoos, is the applicant of record for K253655.

How long did the K253655 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Jul 31, 2026, 253 days later.

← All decisions in July 2026