510(k) Report

Devices descending from K200798

3 later devices reach G-Cem One through their predicates, nearest generation first.

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