510(k) Report

Devices descending from K160097

1 later device reach Image Fast Set, Image Regular Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…Vigodent Indústria E Comercio Ltda20250—