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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 / November 2025 / K252469

510(k) cleared

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA

Dmp Dental Industry S.A. · Nov 6, 2025 · K252469

FDA cleared the MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA from Dmp Dental Industry S.A. on Nov 6, 2025 under K252469, a traditional 510(k). The device falls under product code KLE, Agent, Tooth Bonding, Resin, regulated at 21 CFR 872.3200 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 6, 2025. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Dmp Dental Industry S.A. has one other decision in the tracker over the last 12 months: K253248 (Bright Cavity Liner).

Questions & Answers

What did FDA clear under K252469?

K252469 is the FDA 510(k) for MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA, submitted by Dmp Dental Industry S.A.. FDA's decision date was Nov 6, 2025, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

Dmp Dental Industry S.A., based in Markopoulo, is the applicant of record for K252469.

How long did the K252469 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Nov 6, 2025, 92 days later.

← All decisions in November 2025

Sources