510(k) Report

Devices descending from K963562

383 later devices reach Wright Plaster of Paris Pellets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060809Osteo-Link Bone Void Filler PelletsPromed Advance Technology Co., Ltd.20061—
+1K051698Merries Uni-Osteo, Model CS30250-CS10102Merries International, Inc.20050—
+1K020078Exactech Resorbable Bone PasteExactech, Inc.2004186—
+1K031319Osteo-G Bone Void Filler SystemAspine USA, Inc.20034—
+1K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc.200333—
+1K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC2002162—
+1K013790Calcigen-S Bone Void FilerBiomet Orthopedics, Inc.20026—
+1K991854Osteoplast, Model POP200Interpore Cross Intl.19999—
+1K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Interpore Intl.1998312—
+2K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+2K112857Interface Bone Void FillerBiostructures, LLC20118—
+2K092541InterfaceBiostructures20109—
+2K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp.20101—
+2K083279Caltrix Resorbable Bone Void FillerAg Digital Technology Corp.20090—
+2K073303Norian DrillableSynthes (Usa)200813
+2K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+2K062691ComporusTakiron Co., Ltd.20080—
+2K080917Iroot SPInnovative Bioceramix, Inc.200837—
+2K072444Wellgraft PE IGwowei Technology Co., Ltd.20080—
+2K072170Wellgraft PE IIGwowei Technology Co., Ltd.20080—
+2K071199Bonalive GranulesVivoxid, Ltd.20088—
+2K062607Polygraft BGSSmith & Nephew, Inc.20070—
+2K070998Inion BiorestoreInion OY20074—
+2K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+2K070864Boneplast QS Calcium Sulfate Bone Void FillerBiomet Osteobiologics20070—
+2K063346Pro Osteon 500REbi, L.P.20070—
+2K062459Origen DBM with Bioactive GlassNanotherapeutics200756—
+2K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+2K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120—
+2K060432Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC200619—
+2K060285Bonegen - TRBio-Lok Intl., Inc.20061—
+2K051617Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC20065—
+2K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+2K043209Viagraf DBM PasteOsteotech, Inc.20050—
+2K053098Optium DBM Gel and PuttyLifenet200539—
+2K043048Grafton Plus DBM PasteOsteotech, Inc.20051015
+2K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC2005123—
+2K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511—
+2K040047Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc.2004231
+2K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC200484—
+2K033707Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX…Osteobiologics, Inc.200410—
+2K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+2K040755Exactech Resorbable Room Temperature Bone PasteExactech, Inc.200416—
+2K033611Calcigen -Nap Bone Void FillerBiomet, Inc.20040—
+2K033258Bonesave Bone Void FillerHowmedica Osteonics20043—
+2K030131Ossatura BCP Bone Void FillerIsotis NV2003133—
+2K013960Apatight HA-Bone Graft SubstituteCerabio, LLC20024—
+2K012751Healos Bone Graft MaterialOrquest, Inc.200184—
+2K000515Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201…Interpore Cross Intl.200085—
+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—
+3K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+3K191274BonAlive GranulesBonalive Biomaterials, Ltd.20197—
+3K191764Inion BioRestoreInion OY20190—
+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—
+3K161859MagnetOsXpand Biotechnology BV201712—
+3K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+3K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+3K141189Nanobone / GranulateArtoss GmbH20152—
+3K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+3K141207Novabone Bioactive StripNovabone Products, LLC20140—
+3K130312Iroot FMInnovative Bioceramix, Inc.20140—
+3K133678Confirm BioactiveGlobus Medical, Inc.20140—
+3K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+3K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.20141—
+3K132805BG MorselsProsidyan, Inc.201433—
+3K130977Signify BioactiveGlobus Medical, Inc.20131—
+3K130392Kinex BioactiveGlobus Medical, Inc.20138—
+3K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+3K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp.20130—
+3K111105Curasan Osseolive DentalCurasan AG20120—
+3K120279Nanofuse DBMNanotherapeutics20122—
+3K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+3K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+3K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+3K102208NanogenOrthogen, LLC20110—
+3K110976Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc.201132
+3K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+3K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+3K102722Norian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC201104
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+3K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K090641CuriosProgentix Orthobiology BV200979—
+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—
+3K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092—
+3K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—