510(k) Report

Devices descending from K032597

5 later devices reach Biscem GI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060701Biscem Translucent, Biscem OpaqueBisco, Inc.200642
+2K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd.20083—
+3K180802Meta P&BondMeta Biomed Co., Ltd.20180—
+3K171449MetacemMeta Biomed Co., Ltd.20181—
+4K261166Dia-CemDiaDent Group International20260—