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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 / April 2026 / K260152

510(k) cleared

Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)

Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · Apr 23, 2026 · K260152

FDA cleared the Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) from Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. on Apr 23, 2026 under K260152, a traditional 510(k). The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 20, 2026. The decision came 93 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 Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260152?

K260152 is the FDA 510(k) for Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT), submitted by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.. FDA's decision date was Apr 23, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)?

Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda., based in São Carlos, is the applicant of record for K260152.

How long did the K260152 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Apr 23, 2026, 93 days later.

← All decisions in April 2026