510(k) Report

Devices descending from K091613

5 later devices reach TAKE 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151150ElementsPac-Dent International, Inc.20153—
+1K130869Take 1 AdvanceSybron Dental Specialties20130—
+2K223892DentMix VPS Impression MaterialInnovative Product Brands, Inc.20232—
+3K254152Dia-X Sil Light BodyDiaDent Group International20260—
+3K254142Dia-X Sil Heavy BodyDiaDent Group International20260—