510(k) Report

Devices descending from K111641

6 later devices reach Surgicase Orthognathic Software Wizard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223427Mimics Enlight CMFMaterialise NV20240—
+1K190767AnatomicAlignerThe Methodist Hospital Research Institute D/B/A Houston20200—
+1K161634IPS CaseDesignerNobel Biocare AB20163—
+2K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+2K200810IPS CaseDesignerNobel Biocare AB20201—
+3K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—