510(k) Report

Devices descending from K952614

13 later devices reach Jeltrate Plus Antimicrobial Impr. Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+2K213757Endocem MTA Premixed RegularMaruchi20230—
+2K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+2K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+2K102867Iroot FSInnovative Bioceramix, Inc.20102—
+2K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+3K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+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—
+3K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+4K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+4K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—