510(k) Report

Devices descending from K043005

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+1K063157Merries K-Phate Bone Graft SubstituteMerries International, Inc.20080—
+1K063346Pro Osteon 500REbi, L.P.20070—
+1K050806OptecureExactech, Inc.20063—
+1K051774MBCPBiomatlante200660—
+1K051885MBCPBiomatlante200559—
+2K244006FG Bone Graft MFull Golden Biotech Co., Ltd.20250—
+2K221644Synthetic Bone PuttyVentris Medical20220—
+2K171563MagnetOs PuttyKuros Biosciences B.V20174—
+2K153676Osteon IiiGenoss Co., Ltd.20160—
+2K142276MCS Bone GraftBiostructures, LLC20153—
+2K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+2K103820Reprobone Dental Grafting MaterialCeramisys, Ltd.20110—
+2K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC2010011
+2K090950Bone Plus BCPMegagen Implant Co., Ltd.20101—
+2K093871Periophil B-TCPCytophil, Inc.20100—
+2K093122MBCP+Biomatlante20100—
+2K092788Periophil BiphasicCytophil, Inc.200901
+2K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901
+2K082286BioactysGraftys20091—
+2K082918Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek20091—
+2K082917Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek20093—
+2K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+2K080772Bonemedik-DMMeta Biomed Co., Ltd.20080—
+2K073064Graftys BCPGraftys20082—
+2K071876Cross.BoneTriMed, Inc.20070—
+2K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+2K071912Apaceram Bone Graft SubstitutePentax Corp.20071—
+2K070794AtlantikMedical Biomat20070—
+2K062834Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050Genoss Co., Ltd.20075—
+2K061668Optecure +CCCExactech, Inc.20062—
+2K060732MBCP GelBiomatlante200640—
+3K260364Device 300419 StripGeistlich Pharma AG20260—
+3K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+3K241802Device 300397 PuttyGeistlich Pharma AG20241—
+3K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+3K162860MCS Bone GraftBioventus, LLC20170—
+3K160446MCP Bone PuttyBiostructures, LLC20161—
+3K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+3K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+3K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+3K120602Apaceram Bone Graft SubstituteHoya Corporation20120—
+3K112716Osteon IIGenoss Co., Ltd.20121—
+3K102015Osteon, Osteon Sinus, Osteon LiftingGenoss Co., Ltd.20100—
+3K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc.20090—
+3K082166Mastergraft StripMedtronic Sofamor Danek200938—
+3K080917Iroot SPInnovative Bioceramix, Inc.200837—
+4K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K251818Bontree PlusHudens Bio Co., Ltd.20260—
+4K252890ZenSeal ProKerr Corporation20260—
+4K251556Device 300423 GranulesGeistlich Pharma AG20250—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K240765Porous Biologic ScaffoldVentris Medical20240—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K230486Cove StripSeaSpine Orthopedics Corporation20231—
+4K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+4K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+4K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+4K212991OsteoreviveBone Solutions, Inc.20221—
+4K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+4K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+4K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+4K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—
+4K192363AltaporeBaxter Healthcare Corporation20204—
+4K191513Altapore ShapeBaxter Healthcare Corporation20192—
+4K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+4K190503CeraSealMeta Biomed Co., Ltd.20192—
+4K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+4K181922Sonendo Material ASonendo, Inc.20180—
+4K181721Ceracell Ortho FoamCurasan AG20180—
+4K181225AltaporeBaxter Healthcare Corporation20186—
+4K173525NovoGroOsteonovus, Inc.20180—
+4K170175Endoseal MtaMaruchi20188—
+4K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+4K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+4K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+4K130312Iroot FMInnovative Bioceramix, Inc.20140—
+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—
+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—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+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—