510(k) Report

Devices descending from K082943

12 later devices reach Iroot BP, Model Irbp 4609 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213757Endocem MTA Premixed RegularMaruchi20230—
+1K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+1K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+1K102867Iroot FSInnovative Bioceramix, Inc.20102—
+1K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+2K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+2K243353One-Fil PuttyMediclus Co., Ltd.20251—
+2K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+2K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+2K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+3K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+3K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—