510(k) Report

Devices descending from K901621

3 later devices reach New Per-Fit (R) Improved through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964040Trubyte Soft Reline SystemDentsply Intl.19962—
+2K140146Comfortsoft Soft Denture Liner SystemWhip Mix Corp.20140—
+2K983357Mucopren Soft Relining SystemRoydent Dental Products, Inc.19980—