510(k) Report

Devices descending from K161051

6 later devices reach All-Bond Universal w/BAC (not finalized) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261840BracePaste Prime PlusAmerican Orthodontics20260—
+1K230465Hi-Bond UniversalMediclus Co., Ltd.20232—
+1K213401DIAPLUS UniversalDiaDent Group International20221—
+2K240743Peak Universal BondUltradent Products, Inc.20241—
+2K220804Dia-X Bond UniversalDiaDent Group International20220—
+3K262252MPa Max adhesiveDen-Mat Holdings, LLC20260—