510(k) Report

Devices descending from K120784

6 later devices reach Tuff-Temp 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123265Rmgi Low ViscosityPulpdent Corporation20125—
+2K130223Rmgi FillPulpdent Corporation20134—
+3K250953Equia LC OneGC America, Inc.20250—
+3K192530Surefil one Self-adhesive Composite HybridDentsply Sirona20200—
+3K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation20161—
+4K210045Activa Presto PackPulpdent Corporation20210—