510(k) Report

Devices descending from K121524

3 later devices reach Insignia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203442Inbrace Orthodontic SystemSwift Health Systems, Inc.20211—
+1K123416Insignia with IteroOrmco Corp.20130—
+2K253343Celebrace SoftwareCelebrace20250—