510(k) Report

Devices descending from K053427

5 later devices reach Fresh, Dental Impression Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH20184—
+2K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…Prevest Denpro Limited20223—
+3K251926enCore Impression MaterialEncore Guards20260—
+3K251724Remi Impression MaterialGrindguard, Inc.20261—
+4K261888ClearClub Impression MaterialClearClub20260—