510(k) Report

Devices descending from K120847

75 later devices reach ET/SS Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+1K221752StellaShinhung Mst Co., Ltd.20230—
+1K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+1K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+1K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+1K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+1K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+1K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+1K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+1K140934Hiossen Implant SystemHiossen, Inc.201413—
+1K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+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—
+2K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+2K232528Protective CapNeobiotech Co., Ltd.20240—
+2K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+2K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+2K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+2K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+2K231079LW Retraction CapOssvis Co., Ltd.20230—
+2K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+2K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+2K222636ET Abutment SystemHiossen, Inc.20230—
+2K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+2K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+2K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+2K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+2K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+2K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+2K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+2K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+2K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+2K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+2K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+3K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+3K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+3K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+3K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+3K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+3K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+3K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+3K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.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—
+3K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+3K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+3K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+3K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+3K222976MU SystemDentis Co., Ltd.20230—
+3K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+3K210039CORE1 Implant SystemCybermed, Inc.20220—
+3K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+3K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+3K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+3K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+3K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+3K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+3K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+3K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+4K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+4K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+4K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+4K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+4K220517IBS SystemInnobiosurg Co., Ltd.20220—
+4K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+4K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—