510(k) Report

Devices descending from K964040

2 later devices reach Trubyte Soft Reline System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140146Comfortsoft Soft Denture Liner SystemWhip Mix Corp.20140—
+1K983357Mucopren Soft Relining SystemRoydent Dental Products, Inc.19980—