510(k) Report

Devices descending from K053040

8 later devices reach Paracem Universal DC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222581Stela Automix SystemSdi Limited20221—
+1K222583Stela Capsule SystemSdi Limited20220—
+1K101504TI-Core FlowEssential Dental Systems, Inc.20100—
+1K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+2K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC20240—
+2K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+2K171449MetacemMeta Biomed Co., Ltd.20181—
+3K261166Dia-CemDiaDent Group International20260—