510(k) Report

Devices descending from K062519

9 later devices reach NEXUS 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110508Suglue-103M Espe AG20118—
+2K183465Allcem, Allcem CoreDentscare Ltda20190—
+2K191548Nexus Universal Self-CureKerr Corporation201901
+2K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+3K251946G aenial Universal Injectable IIGC America, Inc.20250—
+3K200798G-Cem OneGC America, Inc.20203—
+4K254109G-Cem UniversalGC America, Inc.20260—
+4K254063iCEM Universal PlusKulzer, LLC20250—
+4K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment…Overfibers S.R.L.20250—