WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / K253248

510(k) cleared

Bright Cavity Liner

Dmp Dental Industry S.A. · Jan 13, 2026 · K253248

FDA cleared the Bright Cavity Liner from Dmp Dental Industry S.A. on Jan 13, 2026 under K253248, a traditional 510(k). The device falls under product code EJK, Liner, Cavity, Calcium Hydroxide, regulated at 21 CFR 872.3250 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 29, 2025. The decision came 106 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: K252469 (MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA).

Questions & Answers

What did FDA clear under K253248?

K253248 is the FDA 510(k) for Bright Cavity Liner, submitted by Dmp Dental Industry S.A.. FDA's decision date was Jan 13, 2026, under product code EJK (Liner, Cavity, Calcium Hydroxide).

Who makes the Bright Cavity Liner?

Dmp Dental Industry S.A., based in Markopoulo, is the applicant of record for K253248.

How long did the K253248 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 13, 2026, 106 days later.

← All decisions in January 2026

Sources