510(k) Report

Devices descending from K080203

21 later devices reach Mta Root Canal Sealer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122892MTA2 Root and Pulp MaterialsAvalon Biomed, Inc.20124—
+1K113568Mta-FillapexPaxmed International201212—
+1K112046Mta AngelusAngelus Industria DE Productos Odontologicos201215—
+2K200174Dia-Root Bio MtaDiaDent Group International20201—
+2K170175Endoseal MtaMaruchi20188—
+2K151047MTA Repair HPAngelus Industria DE Productos Odontologicos20162—
+2K140955MTA2.1 MaterialAvalon Biomed, Inc.20143—
+2K140247Mta FillapexAngelus Industria DE Productos Odontologicos SA20142—
+3K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+3K221811Vista BC SealerInter-Med, Inc.20220—
+3K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+3K211905UltraCal XSUltradent Products, Inc.20210—
+3K202015White ENDOSEAL MTAMaruchi20211—
+3K201799CleaniCalMaruchi20212—
+3K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+3K161239MTA2.2 MaterialAvalon Biomed, Inc.20162—
+4K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+4K212229White Endoseal MTAMaruchi20210—
+4K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+4K181917MTA2.3 MaterialsNuSmile, Ltd.20191—
+5K241457Vista BC PuttyInter-Med, Inc.20240—