510(k) Report

Devices descending from K110508

8 later devices reach Suglue-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183465Allcem, Allcem CoreDentscare Ltda20190—
+1K191548Nexus Universal Self-CureKerr Corporation201901
+1K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+2K251946G aenial Universal Injectable IIGC America, Inc.20250—
+2K200798G-Cem OneGC America, Inc.20203—
+3K254109G-Cem UniversalGC America, Inc.20260—
+3K254063iCEM Universal PlusKulzer, LLC20250—
+3K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—