510(k) Report

Devices descending from K153231

5 later devices reach G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251946G aenial Universal Injectable IIGC America, Inc.20250—
+1K200798G-Cem OneGC America, Inc.20203—
+2K254109G-Cem UniversalGC America, Inc.20260—
+2K254063iCEM Universal PlusKulzer, LLC20250—
+2K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—