510(k) Report

Devices descending from K201790

2 later devices reach Dual Cure Resin Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd.20240—
+1K233082TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd.20230—