510(k) Report

Devices descending from K832654

2 later devices reach Heated Gutta Percha Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042828Obtura Gutta Percha Delivery System, Model 823-700Young O/S, LLC20041—
+2K060347B&L L-Beta, Model WL-B1B&L Biotech Co., Ltd.20060—