K-number	K250714
Device name	FluoroDose Varnish
Applicant	Centrix, Inc.
Product code	LBH
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	872.3260

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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FluoroDose Varnish

Everything you need for a 510(k) submission. Nothing you don't.