510(k) Report

Devices descending from K032268

142 later devices reach MBCP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+4K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K102867Iroot FSInnovative Bioceramix, Inc.20102—
+4K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+5K262050Vioseal XSpident Co., Ltd.20260—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K233259XerosynXerothera, Inc.20240—
+5K240304Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)Enpuno Biotechnology Co., Ltd.20242—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+5K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+5K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+5K213757Endocem MTA Premixed RegularMaruchi20230—
+5K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+5K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+5K221811Vista BC SealerInter-Med, Inc.20220—
+5K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+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—
+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—