510(k) Report

Devices descending from K112118

8 later devices reach Dreambond through their predicates, nearest generation first.

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