510(k) Report

Devices descending from K100245

111 later devices reach HS/HG Prosthetic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+1K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+1K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+1K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+2K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+2K232528Protective CapNeobiotech Co., Ltd.20240—
+2K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+2K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+2K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+2K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+2K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+2K231079LW Retraction CapOssvis Co., Ltd.20230—
+2K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+2K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+2K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+2K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+2K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+2K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+2K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K140934Hiossen Implant SystemHiossen, Inc.201413—
+2K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+2K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+2K123627ET Smartfit AbutmentHiossen, Inc.201321—
+2K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+2K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+3K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+3K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+3K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+3K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+3K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+3K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+3K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+3K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+3K233389EK Digital AbutmentsHiossen, Inc.20240—
+3K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+3K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+3K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+3K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+3K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+3K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+3K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+3K221752StellaShinhung Mst Co., Ltd.20230—
+3K222636ET Abutment SystemHiossen, Inc.20230—
+3K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+3K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+3K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+3K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+3K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+3K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+3K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+3K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+3K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+3K153521IH Implant SystemSewonmedix, Inc.201610—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K152559TruAbutment DSTruabutment201618—
+3K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+3K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+3K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+4K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+4K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+4K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+4K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+4K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+4K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+4K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+4K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+4K222707IH Implant SystemSewonmedix, Inc.20231—
+4K222976MU SystemDentis Co., Ltd.20230—
+4K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+4K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+4K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+4K170259TruAbutment DSTruabutment201717—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+4K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+5K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K240977DenQ Sub SLA Implant SystemDenq20240—
+5K220517IBS SystemInnobiosurg Co., Ltd.20220—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+5K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+5K191913TruAbutment DSTruabutment, Inc.20200—
+5K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K172304TruAbutment DSTruabutment, Inc.20188—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—