510(k) Report

Devices descending from K091678

66 later devices reach HG II Short Fixture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123471Etii SA Fixture SystemHiossen, Inc.201314—
+1K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+2K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+2K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+2K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+2K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+2K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+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—
+3K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+3K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+3K232528Protective CapNeobiotech Co., Ltd.20240—
+3K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+3K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+3K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+3K231079LW Retraction CapOssvis Co., Ltd.20230—
+3K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+3K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+3K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+3K172100URIS OMNI SystemTruabutment, Inc.20187—
+3K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+3K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+3K153521IH Implant SystemSewonmedix, Inc.201610—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+4K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K222707IH Implant SystemSewonmedix, Inc.20231—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240977DenQ Sub SLA Implant SystemDenq20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K220517IBS SystemInnobiosurg Co., Ltd.20220—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+5K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—