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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 / January 2026 / K253253

510(k) cleared

IPDmilled Blanks

Implant Protesis Dental 2004, S.L. · Jan 22, 2026 · K253253

FDA cleared the IPDmilled Blanks from Implant Protesis Dental 2004, S.L. on Jan 22, 2026 under K253253, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 29, 2025. The decision came 115 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 Implant Protesis Dental 2004, S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253253?

K253253 is the FDA 510(k) for IPDmilled Blanks, submitted by Implant Protesis Dental 2004, S.L.. FDA's decision date was Jan 22, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the IPDmilled Blanks?

Implant Protesis Dental 2004, S.L., based in Premià De Dalt (Barcelona), is the applicant of record for K253253.

How long did the K253253 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 22, 2026, 115 days later.

← All decisions in January 2026