510(k) Report

Devices descending from K223518

2 later devices reach iOrtho through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+2K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—