510(k) Report

Devices descending from K063780

10 later devices reach Ace Bond SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131734All-Bond Universal SC (Not Finalized)Bisco, Inc.20140—
+1K112118DreambondBisco, Inc.20118—
+2K201787Light Cure Dental AdhesiveRizhao Huge Biomaterials Company, Ltd.20200—
+2K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc.20166—
+3K261840BracePaste Prime PlusAmerican Orthodontics20260—
+3K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+3K213401DIAPLUS UniversalDiaDent Group International20221—
+4K240743Peak Universal BondUltradent Products, Inc.20241—
+4K220804Dia-X Bond UniversalDiaDent Group International20220—
+5K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—