510(k) Report

Devices descending from K173785

5 later devices reach Custom Clear Aligner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200005Concinnity AlignersDrake Precision Dental Laboratory, Inc.20200—
+1K191308U-AlignerUniversal Orthodontic Laboratory, Inc.20200—
+1K182658BiolinerFive Star Orthodontic Lab & Supply20190—
+1K183643Clear Image AlignersSpecialty Appliance Works, Inc.20191—
+2K192470DenMat Orthodontic AlignersDenmat Holdings, LLC20190—