510(k) Report

Devices descending from K940030

8 later devices reach Bisco Composite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012316Permacem / Permacem DualDmg USA, Inc.20015—
+1K992248Post Cement HI-XBisco, Inc.19990—
+1K982895Sternomega Compomer CementSterngold/Implamed19980—
+2K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical20131—
+2K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+2K030168Agc CemWieland Dental + Technik GmbH & Co. KG20030—
+3K162960TotalC-RamItena Clinical20170—
+3K063444Total Etch Bonding AgentDmg USA, Inc.20070—