510(k) Report

Devices descending from K192846

2 later devices reach Argen Clear Aligner, Argen Clear Aligner Premium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211427CREOKORREKT AlignersCreodent Prosthetics, Ltd.20220—
+1K173738ArchworxUtah Medical Products and Services20210—