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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 / March 2026 / K254112

510(k) cleared

Dia-X Sil Bite

DiaDent Group International · Mar 19, 2026 · K254112

FDA cleared the Dia-X Sil Bite from DiaDent Group International on Mar 19, 2026 under K254112, a traditional 510(k). The device falls under product code ELW, Material, Impression, regulated at 21 CFR 872.3660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 19, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

DiaDent Group International has 3 other decisions in the tracker over the last 12 months: K261166 (DIA-CEM), K261093 (DIAFIL), K261071 (DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)).

Questions & Answers

What did FDA clear under K254112?

K254112 is the FDA 510(k) for Dia-X Sil Bite, submitted by DiaDent Group International. FDA's decision date was Mar 19, 2026, under product code ELW (Material, Impression).

Who makes the Dia-X Sil Bite?

DiaDent Group International, based in Cheongju-Si, is the applicant of record for K254112.

How long did the K254112 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Mar 19, 2026, 90 days later.

← All decisions in March 2026

Sources