510(k) Report

Devices descending from K023042

16 later devices reach PQ1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090355Opal SealUltradent Products, Inc.20092—
+1K063557Peak Bond, Model 5133Ultradent Products, Inc.200612—
+2K242537BracePaste Fluoride SealantAmerican Orthodontics Corp.20240—
+2K210115FiteBac CC OrthoSealLargent Health, LLC20210—
+2K100752Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Ultradent Products, Inc.20107—
+2K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+3K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—
+3K240743Peak Universal BondUltradent Products, Inc.20241—
+3K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+3K171449MetacemMeta Biomed Co., Ltd.20181—
+3K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+4K261166Dia-CemDiaDent Group International20260—
+4K261840BracePaste Prime PlusAmerican Orthodontics20260—
+4K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+4K213401DIAPLUS UniversalDiaDent Group International20221—
+5K220804Dia-X Bond UniversalDiaDent Group International20220—