510(k) Report

Devices descending from K011009

57 later devices reach White Mta Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142178Proroot Mta White, Proroot Mta GrayDentsply International, Inc.20153—
+1K122892MTA2 Root and Pulp MaterialsAvalon Biomed, Inc.20124—
+1K112046Mta AngelusAngelus Industria DE Productos Odontologicos201215—
+1K102575Ortho Mta (Mineral Trioxide Aggregate)Do Co., Ltd.20102—
+1K073218Mta Advanced MaterialDentsply Interntional200822—
+1K063422BioaggregateInnovative Bioceramix, Inc.200638—
+2K252285Well-Root PTVericom Co., Ltd.20250—
+2K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+2K200174Dia-Root Bio MtaDiaDent Group International20201—
+2K162661SavDenTM MTA Root Canal Filling MaterialsTyds Biotech Incorporation20170—
+2K151047MTA Repair HPAngelus Industria DE Productos Odontologicos20162—
+2K130312Iroot FMInnovative Bioceramix, Inc.20140—
+2K140955MTA2.1 MaterialAvalon Biomed, Inc.20143—
+2K132825Retromta-Orthomta IIBiomta20141—
+2K113568Mta-FillapexPaxmed International201212—
+2K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+2K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+2K080917Iroot SPInnovative Bioceramix, Inc.200837—
+2K080203Mta Root Canal SealerDentsply Interntional200821—
+3K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., 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—
+3K230797SmartMTA CapsuleSprig Oral Health Technologies, Inc.20230—
+3K213757Endocem MTA Premixed RegularMaruchi20230—
+3K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+3K211905UltraCal XSUltradent Products, Inc.20210—
+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—
+3K161239MTA2.2 MaterialAvalon Biomed, Inc.20162—
+3K140247Mta FillapexAngelus Industria DE Productos Odontologicos SA20142—
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+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—
+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—
+4K181917MTA2.3 MaterialsNuSmile, Ltd.20191—
+5K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+5K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+5K241457Vista BC PuttyInter-Med, Inc.20240—
+5K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+5K212229White Endoseal MTAMaruchi20210—
+6K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—