510(k) Report

Devices descending from K003034

3 later devices reach Coltene Aura Compomer Restorative System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051502Spi Dental ImplantThommen Medical AG20052—
+2K093615Spi Dental Implant, ElementThommen Medical AG20101—
+3K171795Thommen Implant SystemThommen Medical AG20170—