510(k) Report

Devices descending from K180941

8 later devices reach Ortho System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250198Laon OrthoLaon Medi, Inc.20250—
+1K233625Raydent SWRay Co., Ltd.20242—
+1K232564Align StudioLaon Medi, Inc.20241—
+1K201940Braces on Demand BracketBraces on Demand, Inc.20200—
+1K192244Arcad SmileStudio and Aligner SystemArcadlab20201—
+2K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.20260—
+2K253343Celebrace SoftwareCelebrace20250—
+2K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC20230—