510(k) Report

Devices descending from K142389

3 later devices reach Variolink Esthetic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242572TopCEM-Try in Veneer Try-in GelRizhao Huge Biomaterials Company, Ltd.20240—
+1K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd.20240—
+1K191389Allcem Veneer APSDentscare Ltda20200—