510(k) Report

Devices descending from K080917

37 later devices reach Iroot SP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+1K252890ZenSeal ProKerr Corporation20260—
+1K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+1K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+1K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+1K190503CeraSealMeta Biomed Co., Ltd.20192—
+1K181922Sonendo Material ASonendo, Inc.20180—
+1K170175Endoseal MtaMaruchi20188—
+1K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+1K130312Iroot FMInnovative Bioceramix, Inc.20140—
+1K102867Iroot FSInnovative Bioceramix, Inc.20102—
+1K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+2K262050Vioseal XSpident Co., Ltd.20260—
+2K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+2K240304Injectable 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—
+2K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+2K213757Endocem MTA Premixed RegularMaruchi20230—
+2K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+2K221811Vista BC SealerInter-Med, Inc.20220—
+2K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+2K202015White ENDOSEAL MTAMaruchi20211—
+2K201799CleaniCalMaruchi20212—
+2K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+2K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+2K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+3K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+3K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+3K243353One-Fil PuttyMediclus Co., Ltd.20251—
+3K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+3K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+3K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+3K211905UltraCal XSUltradent Products, Inc.20210—
+3K212229White Endoseal MTAMaruchi20210—
+3K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+4K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+4K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+4K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—