510(k) Report

Devices descending from K031877

3 later devices reach Embrace Wet-Bond Restorative Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072545Artiste SE Flowable Composite, Model N280Pentron Clinical Technologies200721
+2K102603SA Flowable AdhesiveDmg USA, Inc.20101—
+3K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited20240—