510(k) Report

Devices descending from K043005

122 later devices reach Modification to MBCP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+5K202015White ENDOSEAL MTAMaruchi20211—
+5K201799CleaniCalMaruchi20212—
+5K201464Altapore MISBaxter Healthcare Corporation20201—
+5K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+5K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+5K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+5K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+6K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+6K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K243353One-Fil PuttyMediclus Co., Ltd.20251—
+6K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+6K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+6K211905UltraCal XSUltradent Products, Inc.20210—
+6K212229White Endoseal MTAMaruchi20210—
+6K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+7K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+7K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+7K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—