510(k) Report

Devices descending from K183229

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192846Argen Clear Aligner, Argen Clear Aligner PremiumArgen Corporation20202—
+2K211427CREOKORREKT AlignersCreodent Prosthetics, Ltd.20220—
+2K173738ArchworxUtah Medical Products and Services20210—