510(k) Report

Devices descending from K883842

15 later devices reach Dental Alginate Impression Material W/Anti. Addi. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K965083Super-Dent Alginate,Normal Set, Fast Set,Super Deluxe Dustless Alginate, Normal Set…S.S. White Mfg., Ltd.19970—
+1K952614Jeltrate Plus Antimicrobial Impr. MaterialDentsply Intl.199613—
+2K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+3K213757Endocem MTA Premixed RegularMaruchi20230—
+3K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+3K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+3K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+4K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+4K243353One-Fil PuttyMediclus Co., Ltd.20251—
+4K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+4K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+4K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+5K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+5K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—