510(k) Report

Devices descending from K192153

2 later devices reach Portux CAD/CAM Disc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212017Thermeo SystemPro3Dure Medical GmbH20221—
+2K260031Thermeo® I MsiPro3Dure Medical GmbH20260—