510(k) Report

Devices descending from K970321

296 later devices reach Bio-Oss Anorganic Bovine Bone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+3K042707Grafton Plus DBM PasteOsteotech, Inc.2005013
+3K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC200484—
+3K033398Laryngeal Augmentation ImplantBioform, Inc.200310—
+4K254210Rebohil (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd.20260—
+4K253317Cytrans™ ElashieldGC America, Inc.20260—
+4K253883Bonalive MaxillofacialBonalive, Ltd.20260—
+4K250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.20250—
+4K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG20250—
+4K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…Geistlich Pharma AG20250—
+4K250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AG20250—
+4K233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.20240—
+4K221808InterOss CollagenSigmagraft, Inc.20230—
+4K212156ABCcolla Bone MatrixAcro Biomedical Co., Ltd.20210—
+4K201859Porcine Mineral Collagen Composite MoldableCollagen Matrix, Inc.20200—
+4K192597Cytrans GranulesGC America, Inc.20200—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K191764Inion BioRestoreInion OY20190—
+4K173188The Graft Natural Bone SubstitutePurgo Biologics, Inc.20181—
+4K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+4K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.20171—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K141189Nanobone / GranulateArtoss GmbH20152—
+4K130312Iroot FMInnovative Bioceramix, Inc.20140—
+4K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+4K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+4K092608Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20100—
+4K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+4K082166Mastergraft StripMedtronic Sofamor Danek200938—
+4K090793Bongros HABioalpha, Inc.20090—
+4K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+4K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092—
+4K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+4K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+4K080917Iroot SPInnovative Bioceramix, Inc.200837—
+4K071663VF Gel PlusCoapt Systems, Inc.20084—
+4K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+4K051617Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC20065—
+5K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K252890ZenSeal ProKerr Corporation20260—
+5K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+5K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+5K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+5K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+5K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+5K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+5K213757Endocem MTA Premixed RegularMaruchi20230—
+5K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+5K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+5K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+5K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+5K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+5K191737The Graft Bone SubstitutePurgo Biologics, Inc.20200—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+5K190503CeraSealMeta Biomed Co., Ltd.20192—
+5K181922Sonendo Material ASonendo, Inc.20180—
+5K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+5K170175Endoseal MtaMaruchi20188—
+5K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+5K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+5K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K161351NanoBone SBX PuttyArtoss GmbH20161—
+5K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+5K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+5K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+5K141207Novabone Bioactive StripNovabone Products, LLC20140—
+5K133678Confirm BioactiveGlobus Medical, Inc.20140—
+5K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+5K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+5K130392Kinex BioactiveGlobus Medical, Inc.20138—
+5K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+5K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+5K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+5K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+5K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+5K102867Iroot FSInnovative Bioceramix, Inc.20102—
+5K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+5K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+5K081815Vocalis GelCytophil, Inc.20090—
+5K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+5K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+6K262050Vioseal XSpident Co., Ltd.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+6K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K243353One-Fil PuttyMediclus Co., Ltd.20251—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K240765Porous Biologic ScaffoldVentris Medical20240—
+6K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240304Injectable 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—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—