510(k) Report

Devices descending from K232653

1 later device reach Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—