510(k) Report

Devices descending from K011386

188 later devices reach Ebi Osteostim Granules-Resorbable Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033611Calcigen -Nap Bone Void FillerBiomet, Inc.20040—
+1K020078Exactech Resorbable Bone PasteExactech, Inc.2004186—
+2K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+2K080917Iroot SPInnovative Bioceramix, Inc.200837—
+2K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+2K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120—
+2K043209Viagraf DBM PasteOsteotech, Inc.20050—
+2K053098Optium DBM Gel and PuttyLifenet200539—
+2K043048Grafton Plus DBM PasteOsteotech, Inc.20051015
+2K040755Exactech Resorbable Room Temperature Bone PasteExactech, Inc.200416—
+3K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+3K252890ZenSeal ProKerr Corporation20260—
+3K242799PliaFX FloLifenet Health20240—
+3K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+3K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+3K221644Synthetic Bone PuttyVentris Medical20220—
+3K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+3K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+3K190503CeraSealMeta Biomed Co., Ltd.20192—
+3K181922Sonendo Material ASonendo, Inc.20180—
+3K170175Endoseal MtaMaruchi20188—
+3K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+3K171563MagnetOs PuttyKuros Biosciences B.V20174—
+3K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+3K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+3K130312Iroot FMInnovative Bioceramix, Inc.20140—
+3K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+3K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+3K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+3K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+3K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+3K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+3K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+3K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+3K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+3K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+3K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+3K063050Cap PlusEtex Corp.200734—
+3K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+3K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069—
+3K050806OptecureExactech, Inc.20063—
+4K262050Vioseal XSpident Co., Ltd.20260—
+4K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+4K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+4K240304Injectable 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—
+4K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+4K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K213757Endocem MTA Premixed RegularMaruchi20230—
+4K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+4K221811Vista BC SealerInter-Med, Inc.20220—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+4K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+4K202015White ENDOSEAL MTAMaruchi20211—
+4K201799CleaniCalMaruchi20212—
+4K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+4K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+4K173424BioSphere FlexSynergy Biomedical20180—
+4K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+4K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+4K163310NovaBone IRMNovabone Products, LLC20170—
+4K160978LITe BIO Delivery SystemStryker Corporation20160—
+4K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+4K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+4K132868CarricellEtex Corporation20153—
+4K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+4K141207Novabone Bioactive StripNovabone Products, LLC20140—
+4K133678Confirm BioactiveGlobus Medical, Inc.20140—
+4K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+4K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.20141—
+4K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+4K132805BG MorselsProsidyan, Inc.201433—
+4K130977Signify BioactiveGlobus Medical, Inc.20131—
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+4K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+4K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+4K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+4K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+4K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+4K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+4K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+4K090310EquivaboneEtex Corp.200928—
+4K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+4K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+4K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+4K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+4K061668Optecure +CCCExactech, Inc.20062—
+5K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+5K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—