510(k) Report

Devices descending from K161689

38 later devices reach OSSTEM Implant System - Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+1K232528Protective CapNeobiotech Co., Ltd.20240—
+1K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+1K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+1K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+1K231079LW Retraction CapOssvis Co., Ltd.20230—
+1K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+1K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+1K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+1K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+1K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+1K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+1K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+2K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+2K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+2K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+2K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+2K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+2K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+2K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+2K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+2K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+2K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+2K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+2K222636ET Abutment SystemHiossen, Inc.20230—
+2K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+2K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+2K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+3K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+3K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+3K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+3K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+3K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+3K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+3K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+3K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+3K222976MU SystemDentis Co., Ltd.20230—