510(k) Report

Devices descending from K171295

13 later devices reach ULab Systems Treatment Planning Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212770VisionSoftsmile, Inc.20212—
+1K200772ULab Systems uDesign SoftwareUlab Systems, Inc.20200—
+1K180941Ortho System3Shape A/S20188—
+2K252507SmileInspectorAmv Consulting, LLC20260—
+2K250198Laon OrthoLaon Medi, Inc.20250—
+2K233625Raydent SWRay Co., Ltd.20242—
+2K232564Align StudioLaon Medi, Inc.20241—
+2K233616Clevaligner Software (V1.0.0)Clevaligner, Ltd.20240—
+2K201940Braces on Demand BracketBraces on Demand, Inc.20200—
+2K192244Arcad SmileStudio and Aligner SystemArcadlab20201—
+3K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.20260—
+3K253343Celebrace SoftwareCelebrace20250—
+3K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC20230—