510(k) Report

Devices descending from K100854

1 later device reach Premium Plus Disposable Prophy Angle Model 3399 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited20250—