510(k) Report

Devices descending from K012316

5 later devices reach Permacem / Permacem Dual through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical20131—
+1K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+1K030168Agc CemWieland Dental + Technik GmbH & Co. KG20030—
+2K162960TotalC-RamItena Clinical20170—
+2K063444Total Etch Bonding AgentDmg USA, Inc.20070—