510(k) Report

Devices descending from K941780

159 later devices reach Orthovita Biogran through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp.1996158—
+2K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+2K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+2K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+2K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+2K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC200485—
+2K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC200480—
+2K031073Perioglas Plus - Settable Bone Graft SubstituteNovabone Products, LLC20031—
+3K241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.20250—
+3K153230ShefaBone SCPC Resorbable Bone GraftThe Implantech Inc./Shefabone20160—
+3K111105Curasan Osseolive DentalCurasan AG20120—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+3K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+3K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+3K070998Inion BiorestoreInion OY20074—
+3K070784Inion BiorestoreInion OY20070—
+3K070055Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20071—
+3K063422BioaggregateInnovative Bioceramix, Inc.200638—
+3K042707Grafton Plus DBM PasteOsteotech, Inc.2005013
+3K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518—
+3K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC200484—
+4K253883Bonalive MaxillofacialBonalive, Ltd.20260—
+4K243745FG Bone Graft BFull Golden Biotech Corporation20250—
+4K191764Inion BioRestoreInion OY20190—
+4K141189Nanobone / GranulateArtoss GmbH20152—
+4K130312Iroot FMInnovative Bioceramix, Inc.20140—
+4K131385Easy-GraftDegradable Solutions AG20130—
+4K113282Cerasorb Dental,Ceradorb M Dental, Cerasorb PerioRiemser Arzeimittel AG20120—
+4K120152Cerasorb PlusRiemser Arzneimittel AG20120—
+4K110198Blue Sky Bio TCPBlue Sky Bio, LLC20110—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K103709Ceracell DentalCurasan AG20111—
+4K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+4K091618VitomatrixOrthovita, Inc.20100—
+4K101426Ceros TCP GranulesMathys, Ltd.20100—
+4K090950Bone Plus BCPMegagen Implant Co., Ltd.20101—
+4K092194Polybone DentalKyung Won Medical Co., Ltd.20100—
+4K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+4K093122MBCP+Biomatlante20100—
+4K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc.20090—
+4K083372Arrowbone-a, Arrowbone-BBrainbase Corporation20091—
+4K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+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—
+4K081561Osferion DOlympus Terumo Biomaterials Corporation20081—
+4K080917Iroot SPInnovative Bioceramix, Inc.200837—
+4K062102OdoncerTeknimed, S.A.20070—
+4K051617Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC20065—
+4K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG20062—
+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—
+5K213260CMFlexTMDimension Inx Corp.20220—
+5K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+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—
+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—
+5K161351NanoBone SBX PuttyArtoss GmbH20161—
+5K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+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—
+5K130392Kinex BioactiveGlobus Medical, Inc.20138—
+5K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+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—
+6K262050Vioseal XSpident Co., Ltd.20260—
+6K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+6K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K243353One-Fil PuttyMediclus Co., Ltd.20251—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+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—
+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—
+6K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+6K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+6K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+6K221811Vista BC SealerInter-Med, Inc.20220—
+6K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—