510(k) Report

Devices descending from K040278

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.20250—
+1K153230ShefaBone SCPC Resorbable Bone GraftThe Implantech Inc./Shefabone20160—
+1K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+1K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+1K070998Inion BiorestoreInion OY20074—
+1K070784Inion BiorestoreInion OY20070—
+1K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+1K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+1K063422BioaggregateInnovative Bioceramix, Inc.200638—
+1K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+1K042707Grafton Plus DBM PasteOsteotech, Inc.2005013
+1K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518—
+2K243745FG Bone Graft BFull Golden Biotech Corporation20250—
+2K191764Inion BioRestoreInion OY20190—
+2K130312Iroot FMInnovative Bioceramix, Inc.20140—
+2K131385Easy-GraftDegradable Solutions AG20130—
+2K111105Curasan Osseolive DentalCurasan AG20120—
+2K113282Cerasorb Dental,Ceradorb M Dental, Cerasorb PerioRiemser Arzeimittel AG20120—
+2K120152Cerasorb PlusRiemser Arzneimittel AG20120—
+2K110198Blue Sky Bio TCPBlue Sky Bio, LLC20110—
+2K103709Ceracell DentalCurasan AG20111—
+2K091618VitomatrixOrthovita, Inc.20100—
+2K101426Ceros TCP GranulesMathys, Ltd.20100—
+2K090950Bone Plus BCPMegagen Implant Co., Ltd.20101—
+2K092194Polybone DentalKyung Won Medical Co., Ltd.20100—
+2K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+2K093122MBCP+Biomatlante20100—
+2K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc.20090—
+2K083372Arrowbone-a, Arrowbone-BBrainbase Corporation20091—
+2K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+2K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092—
+2K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K081561Osferion DOlympus Terumo Biomaterials Corporation20081—
+2K080917Iroot SPInnovative Bioceramix, Inc.200837—
+2K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+2K070055Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20071—
+2K062102OdoncerTeknimed, S.A.20070—
+2K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG20062—
+3K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+3K253883Bonalive MaxillofacialBonalive, Ltd.20260—
+3K252890ZenSeal ProKerr Corporation20260—
+3K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+3K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+3K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+3K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+3K213757Endocem MTA Premixed RegularMaruchi20230—
+3K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+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—
+3K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+3K170175Endoseal MtaMaruchi20188—
+3K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+3K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+3K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+3K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+4K262050Vioseal XSpident Co., Ltd.20260—
+4K243353One-Fil PuttyMediclus Co., Ltd.20251—
+4K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+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—
+4K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221811Vista BC SealerInter-Med, Inc.20220—
+4K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+4K202015White ENDOSEAL MTAMaruchi20211—
+4K201799CleaniCalMaruchi20212—
+4K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+4K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+5K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+5K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+5K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+5K211905UltraCal XSUltradent Products, Inc.20210—
+5K212229White Endoseal MTAMaruchi20210—
+6K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—