510(k) Report

Devices descending from K001730

17 later devices reach GC Fujicem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182854GC FujiCEM 2 (Improved)GC America, Inc.20191—
+1K1911223M RelyX Pediatric Resin Modified Glass Ionomer Cement3M Espe Dental Products20190—
+1K022476Relyx Rmgip3M Company200215—
+2K214118Riva Cem AutomixSdi Limited20220—
+2K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical20131—
+2K111185Relyx Luting Plus Automix3M Espe Dental Products201110—
+2K031494Doc's Best White Copper CementCooley & Cooley, Ltd.20030—
+2K023649Vitique SystemDmg USA, Inc.20030—
+3K250566EsCem RMGISpident Co., Ltd.20250—
+3K162960TotalC-RamItena Clinical20170—
+3K123595Nexus RmgiKerr Corporation20130—
+3K123265Rmgi Low ViscosityPulpdent Corporation20125—
+4K130223Rmgi FillPulpdent Corporation20134—
+5K250953Equia LC OneGC America, Inc.20250—
+5K192530Surefil one Self-adhesive Composite HybridDentsply Sirona20200—
+5K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation20161—
+6K210045Activa Presto PackPulpdent Corporation20210—