510(k) Report

Devices descending from K000211

5 later devices reach Build-IT FR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132115Absolute Dentin 2Parkell, Inc.20140—
+1K102703Build-IT Total CorePentron Clinical20113—
+2K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited20240—
+2K153127everX PosteriorGC America, Inc.20161—
+3K192260everX FlowGC America, Inc.20190—