510(k) Report

Devices descending from K092715

7 later devices reach Iroot BP Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+1K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+1K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+1K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+1K102867Iroot FSInnovative Bioceramix, Inc.20102—
+2K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+2K213757Endocem MTA Premixed RegularMaruchi20230—