510(k) Report

Devices descending from K111958

15 later devices reach Tetric Evoceram Bulk Fill through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190758Opus Bulk Fill APS, Opus Bulk Fill Flow APSDentscare Ltda20190—
+1K183380Tetric PowerFillIvoclar Vivadent, AG20192—
+1K150393Tetric Evoflow Bulk FillIvoclar Vivadent, AG20150—
+1K141081Filtek Bulk Fill Posterior Restroative3M Espe Dental Products20149—
+2K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.20260—
+2K254245Zafira®New Stetic, SA20260—
+2K1834763M Filtek Universal Restorative3M Espe Dental Products20195—
+2K171147REVEAL BulkBisco, Inc.20170—
+2K163207Filtek One Bulk Fill Restorative3M Company20161—
+3K241147Any-ComMediclus Co., Ltd.20241—
+3K231523EsCom250Spident Co., Ltd.20230—
+3K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation20220—
+3K191306Llis, Vittra APSDentscare Ltda20191—
+4K250823Any-Com FlowMediclus Co., Ltd.20250—
+4K210231Vittra APS UniqueDentscare Ltda20210—