510(k) Report

Devices descending from K994261

3 later devices reach Ultratemp Temporary Polycarboxylate Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080768Ultratemp Firm, Fast and Regular SetUltradent Products, Inc.20082—
+2K211237UltraTemp Rez IIUltradent Products, Inc.20211—
+3K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak20260—