510(k) Report

Devices descending from K981620

6 later devices reach Mta Material II through their predicates, nearest generation first.

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