Cleared Traditional

FluoroDose Varnish

K250714 · Centrix, Inc. · Dental
Nov 2025
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K250714 is an FDA 510(k) clearance for the FluoroDose Varnish, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on November 21, 2025, 256 days after receiving the submission on March 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K250714 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2025
Decision Date November 21, 2025
Days to Decision 256 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

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