510(k) Report

Devices descending from K082449

6 later devices reach Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261166Dia-CemDiaDent Group International20260—
+1K231552Dia-CemDiaDent Group International20231—
+1K193260U-Cem Premium & MAZIC CemVericom Co., Ltd.20200—
+1K161256TheraCemBisco, Inc.20161—
+2K254201Any-CemMediclus Co., Ltd.20260—
+2K192007TheraBase, TheraBase CaBisco, Inc.20200—