510(k) Report

Devices descending from K970321

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151209InterOssSigmagraft, Inc.20150—
+1K123876SynergyOdontit S.A.20140—
+1K131385Easy-GraftDegradable Solutions AG20130—
+1K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG201321—
+1K113246OCS-BNibec Company, Limited20131—
+1K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG201123—
+1K111816EquimatrixLuitpold Pharmaceuticals, Inc.20111—
+1K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518—
+1K040501DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation20053—
+1K040646Straumann GranulesThe Straumann Co.20042—
+1K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma2004124—
+1K992416Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp.1999189—
+2K253723BOSSMedpark Co., Ltd.20260—
+2K243745FG Bone Graft BFull Golden Biotech Corporation20250—
+2K242510Geistlich Bio-Flow®Geistlich Pharma AG20250—
+2K230305THE Graft CollagenPurgo Biologics, Inc.20240—
+2K240661Geistlich Bio-Oss®Geistlich Pharma AG20242—
+2K231672S1Medpark Co., Ltd.20230—
+2K211551Wishbone HAWishbone SA20210—
+2K202183Porcine Mineral Collagen CompositeCollagen Matrix, Inc.20210—
+2K201051Straumann BoneCeramicInstitut Straumann AG20200—
+2K193212DSM Biomedical Dental Bone Graft PlusDsm Biomedical20200—
+2K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG20199—
+2K173594Straumann ceraboneInstitut Straumann AG20180—
+2K163714Ossix BoneDatum Dental, Ltd.20170—
+2K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical20170—
+2K140021TI-OSSChiyewon20150—
+2K111105Curasan Osseolive DentalCurasan AG20120—
+2K113282Cerasorb Dental,Ceradorb M Dental, Cerasorb PerioRiemser Arzeimittel AG20120—
+2K120152Cerasorb PlusRiemser Arzneimittel AG20120—
+2K120601Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G…Geistlich Pharma AG201216
+2K112575Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG201111—
+2K110198Blue Sky Bio TCPBlue Sky Bio, LLC20110—
+2K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+2K103820Reprobone Dental Grafting MaterialCeramisys, Ltd.20110—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K103709Ceracell DentalCurasan AG20111—
+2K091618VitomatrixOrthovita, Inc.20100—
+2K101426Ceros TCP GranulesMathys, Ltd.20100—
+2K091424Osta Maxigro and RegigroOsta Technologies20100—
+2K090950Bone Plus BCPMegagen Implant Co., Ltd.20101—
+2K092194Polybone DentalKyung Won Medical Co., Ltd.20100—
+2K092428Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie201029—
+2K093122MBCP+Biomatlante20100—
+2K090401OrthossEd. Geistlich Soehne AG Fur Chemische Industrie20103—
+2K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc.20090—
+2K083372Arrowbone-a, Arrowbone-BBrainbase Corporation20091—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K081561Osferion DOlympus Terumo Biomaterials Corporation20081—
+2K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.200816—
+2K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+2K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation20082—
+2K062102OdoncerTeknimed, S.A.20070—
+2K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+2K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+2K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG20062—
+2K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+2K050170Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd.20050—
+2K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc.2005553
+2K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC200485—
+2K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC200480—
+2K031073Perioglas Plus - Settable Bone Graft SubstituteNovabone Products, LLC20031—
+2K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc.200315—
+3K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG20250—
+3K251613SwissGraft XGeistlich Pharma AG20250—
+3K241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.20250—
+3K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC20240—
+3K230091THE CoverPurgo Biologics, Inc.20230—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG20223—
+3K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG20213—
+3K190754Orthoss (R)Geistlich Pharma AG20190—
+3K171629ABCcolla Bone GraftAcro Biomedical Co., Ltd.20181—
+3K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc.20170—
+3K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG201710—
+3K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.20170—
+3K153230ShefaBone SCPC Resorbable Bone GraftThe Implantech Inc./Shefabone20160—
+3K142040Ocs-B CollagenNibec Co., Ltd.20152—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K140714Porcine Anorganic Bone MineralCollagen Matrix, Inc.201442
+3K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+3K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+3K111364Haptite Coating Implant SystemDentis Co., Ltd.20121—
+3K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+3K083742Synoss Collagen Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20090—
+3K082463ProgenixMedtronic Sofamor Danek20080—
+3K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp20080—
+3K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+3K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp20080—
+3K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+3K080772Bonemedik-DMMeta Biomed Co., Ltd.20080—
+3K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+3K072397Synoss Synthetic Bone Graft MaterialCollagen Matrix, Inc.20073—
+3K070998Inion BiorestoreInion OY20074—
+3K070784Inion BiorestoreInion OY20070—
+3K070055Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20071—
+3K062200Collagen Matrix Anorganic Bone Mineral Bone Graft MaterialsCollagen Matrix, Inc.20070—
+3K063422BioaggregateInnovative Bioceramix, Inc.200638—