510(k) Report

Devices descending from K062166

2 later devices reach Enamel Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc.20110—
+1K100539Preventech Prophylaxis Paste with FluoridePreventive Technologies, Inc.20100—