510(k) Report

Devices descending from K192436

5 later devices reach Healing Abutments and Cover Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210826Healing Abutment, Cover ScrewMegagen Implant Co., Ltd.20224—
+2K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+2K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+2K230203Dentis I-FIX AbutmentDentis Co., Ltd.20230—
+3K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—