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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 / K250714

510(k) cleared

FluoroDose Varnish

Centrix, Inc. · Nov 21, 2025 · K250714

FDA cleared the FluoroDose Varnish from Centrix, Inc. on Nov 21, 2025 under K250714, a traditional 510(k). The device falls under product code LBH, Varnish, Cavity, regulated at 21 CFR 872.3260 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 10, 2025. The decision came 256 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 Centrix, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250714?

K250714 is the FDA 510(k) for FluoroDose Varnish, submitted by Centrix, Inc.. FDA's decision date was Nov 21, 2025, under product code LBH (Varnish, Cavity).

Who makes the FluoroDose Varnish?

Centrix, Inc., based in Shelton, CT, is the applicant of record for K250714.

How long did the K250714 review take?

FDA received the submission on Mar 10, 2025 and issued its decision on Nov 21, 2025, 256 days later.

← All decisions in November 2025