510(k) Report

Devices descending from K992416

189 later devices reach Perioglas- Bioglass Bone Graft Particulate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+4K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+4K081815Vocalis GelCytophil, Inc.20090—
+4K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+4K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+5K262050Vioseal XSpident 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—
+5K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+5K243353One-Fil PuttyMediclus Co., Ltd.20251—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+5K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240304Injectable 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—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+5K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K221811Vista BC SealerInter-Med, Inc.20220—
+5K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+5K202015White ENDOSEAL MTAMaruchi20211—
+5K201799CleaniCalMaruchi20212—
+5K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+5K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+5K190371Morpheus-CBiogennix, LLC20190—
+5K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+5K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+5K180631Silk VoiceSofregen Medical, Inc.20181—
+5K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+5K163310NovaBone IRMNovabone Products, LLC20170—
+5K160978LITe BIO Delivery SystemStryker Corporation20160—
+5K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+5K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+5K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+5K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+5K132805BG MorselsProsidyan, Inc.201433—
+5K130977Signify BioactiveGlobus Medical, Inc.20131—
+5K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+5K083783VF LiquigelCoapt Systems, Inc.20090—
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+6K240919Silk Voice (SMI-04)Sofregen Medical20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+6K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+6K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+6K211905UltraCal XSUltradent Products, Inc.20210—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K212229White Endoseal MTAMaruchi20210—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+7K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—