510(k) Report

Devices descending from K111828

3 later devices reach Clearsplint ES through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation20250—
+1K212017Thermeo SystemPro3Dure Medical GmbH20221—
+2K260031Thermeo® I MsiPro3Dure Medical GmbH20260—