510(k) Report

Devices descending from K931309

14 later devices reach Variolink through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.20165—
+1K111836Permashade Veneer CementUltradent Products, Inc.20110—
+1K012316Permacem / Permacem DualDmg USA, Inc.20015—
+1K982895Sternomega Compomer CementSterngold/Implamed19980—
+2K251946G aenial Universal Injectable IIGC America, Inc.20250—
+2K200798G-Cem OneGC America, Inc.20203—
+2K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical20131—
+2K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+2K030168Agc CemWieland Dental + Technik GmbH & Co. KG20030—
+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—
+3K162960TotalC-RamItena Clinical20170—
+3K063444Total Etch Bonding AgentDmg USA, Inc.20070—