510(k) Report

Devices descending from K210826

4 later devices reach Healing Abutment, Cover Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+1K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+1K230203Dentis I-FIX AbutmentDentis Co., Ltd.20230—
+2K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—