510(k) Report

Devices descending from K964174

8 later devices reach Mineral Trioxide Aggregate (Mta) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981620Mta Material IIDentsply Intl.19986—
+1K980332Mta MaterialDentsply Intl.19987—
+2K142178Proroot Mta White, Proroot Mta GrayDentsply International, Inc.20153—
+2K112078Endocem Mta (Mineral Trioxide Aggregate)Maruchi20121—
+3K252285Well-Root PTVericom Co., Ltd.20250—
+3K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+3K162661SavDenTM MTA Root Canal Filling MaterialsTyds Biotech Incorporation20170—
+3K133042Endocem ZRMaruchi20140—