510(k) Report

Devices descending from K952922

190 later devices reach Biogran Bioactive Glass Synthetic Bone Graft Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.200816—
+1K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC200485—
+1K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc.200315—
+1K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp.1996158—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+2K111364Haptite Coating Implant SystemDentis Co., Ltd.20121—
+2K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+2K101426Ceros TCP GranulesMathys, Ltd.20100—
+2K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+2K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+2K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+2K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+2K042707Grafton Plus DBM PasteOsteotech, Inc.2005013
+2K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC200484—
+2K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC200480—
+2K033398Laryngeal Augmentation ImplantBioform, Inc.200310—
+2K031073Perioglas Plus - Settable Bone Graft SubstituteNovabone Products, LLC20031—
+3K241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.20250—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K153230ShefaBone SCPC Resorbable Bone GraftThe Implantech Inc./Shefabone20160—
+3K141189Nanobone / GranulateArtoss GmbH20152—
+3K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+3K111105Curasan Osseolive DentalCurasan AG20120—
+3K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+3K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+3K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+3K071663VF Gel PlusCoapt Systems, Inc.20084—
+3K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+3K070998Inion BiorestoreInion OY20074—
+3K070784Inion BiorestoreInion OY20070—
+3K070055Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20071—
+3K063422BioaggregateInnovative Bioceramix, Inc.200638—
+3K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+3K051617Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC20065—
+3K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518—
+4K253883Bonalive MaxillofacialBonalive, Ltd.20260—
+4K243745FG Bone Graft BFull Golden Biotech Corporation20250—
+4K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+4K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K191764Inion BioRestoreInion OY20190—
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K161351NanoBone SBX PuttyArtoss GmbH20161—
+4K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+4K141207Novabone Bioactive StripNovabone Products, LLC20140—
+4K130312Iroot FMInnovative Bioceramix, Inc.20140—
+4K133678Confirm BioactiveGlobus Medical, Inc.20140—
+4K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+4K131385Easy-GraftDegradable Solutions AG20130—
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+4K113282Cerasorb Dental,Ceradorb M Dental, Cerasorb PerioRiemser Arzeimittel AG20120—
+4K120152Cerasorb PlusRiemser Arzneimittel AG20120—
+4K110198Blue Sky Bio TCPBlue Sky Bio, LLC20110—
+4K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+4K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+4K103709Ceracell DentalCurasan AG20111—
+4K091618VitomatrixOrthovita, Inc.20100—
+4K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+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—
+4K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092—
+4K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+4K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+4K081815Vocalis GelCytophil, Inc.20090—
+4K081561Osferion DOlympus Terumo Biomaterials Corporation20081—
+4K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+4K080917Iroot SPInnovative Bioceramix, Inc.200837—
+4K062102OdoncerTeknimed, S.A.20070—
+4K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+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—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+5K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K252890ZenSeal ProKerr Corporation20260—
+5K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+5K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—