510(k) Report

Devices descending from K020986

158 later devices reach Mastergraft Resorbable Ceramic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212156ABCcolla Bone MatrixAcro Biomedical Co., Ltd.20210—
+4K201464Altapore MISBaxter Healthcare Corporation20201—
+4K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+4K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+4K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+4K120602Apaceram Bone Graft SubstituteHoya Corporation20120—
+4K112716Osteon IIGenoss Co., Ltd.20121—
+4K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+4K102015Osteon, Osteon Sinus, Osteon LiftingGenoss Co., Ltd.20100—
+4K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+4K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+4K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+4K080917Iroot SPInnovative Bioceramix, Inc.200837—
+4K061668Optecure +CCCExactech, Inc.20062—
+5K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K251818Bontree PlusHudens Bio Co., Ltd.20260—
+5K252890ZenSeal ProKerr Corporation20260—
+5K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K240442MagnetOs PuttyKuros Biosciences B.V20243—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+5K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+5K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+5K190503CeraSealMeta Biomed Co., Ltd.20192—
+5K181922Sonendo Material ASonendo, Inc.20180—
+5K170175Endoseal MtaMaruchi20188—
+5K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+5K130312Iroot FMInnovative Bioceramix, Inc.20140—
+5K102867Iroot FSInnovative Bioceramix, Inc.20102—
+5K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+6K262050Vioseal XSpident Co., Ltd.20260—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K240304Injectable 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—
+6K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+6K213757Endocem MTA Premixed RegularMaruchi20230—
+6K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+6K221811Vista BC SealerInter-Med, Inc.20220—
+6K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+6K202015White ENDOSEAL MTAMaruchi20211—
+6K201799CleaniCalMaruchi20212—
+6K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+6K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+6K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+7K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+7K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+7K243353One-Fil PuttyMediclus Co., Ltd.20251—
+7K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+7K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+7K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+7K211905UltraCal XSUltradent Products, Inc.20210—
+7K212229White Endoseal MTAMaruchi20210—
+7K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+8K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+8K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+8K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—