510(k) Report

Devices descending from K172281

2 later devices reach PuRE PMMA Disc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261456Ruthinium DiscDental Manufacturing S.p.A.20260—
+1K201563PuRE PMMA DiscQuest Dental USA Corp.20210—