510(k) Report

Devices descending from K063557

12 later devices reach Peak Bond, Model 5133 through their predicates, nearest generation first.

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