510(k) Report

Devices descending from K011159

5 later devices reach One-Step Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093014American Dental Products SE BondeasyAmerican Dental Products, Inc.20100—
+1K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+2K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+2K171449MetacemMeta Biomed Co., Ltd.20181—
+3K261166Dia-CemDiaDent Group International20260—