510(k) Report

Devices descending from K090355

2 later devices reach Opal Seal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242537BracePaste Fluoride SealantAmerican Orthodontics Corp.20240—
+1K210115FiteBac CC OrthoSealLargent Health, LLC20210—