510(k) Report

Devices descending from K150217

5 later devices reach Orthophos SL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L20220—
+1K201140AxeosDentsply Sirona20201—
+1K191616Orthophos SDentsply Sirona20190—
+1K161131FONA Pan/CephFona S.R.L20160—
+2K253959Primevision 3DDentsply Sirona20260—