510(k) Report

Devices descending from K082213

110 later devices reach GS Iii Fixture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+1K091208GS Iii SystemOsstem Implant Co., Ltd.201028—
+1K093352HG Iii Fixture SystemHiossen, Inc.2009105—
+2K131165Anker Dental Implant SystemAlliance Global20131—
+2K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+2K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+2K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+3K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+3K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+3K222738Point implant systemPointnix Co., Ltd.20230—
+3K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+3K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+3K172100URIS OMNI SystemTruabutment, Inc.20187—
+3K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+3K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+3K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+3K153521IH Implant SystemSewonmedix, Inc.201610—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+3K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K123471Etii SA Fixture SystemHiossen, Inc.201314—
+3K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+3K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+3K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+3K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+4K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+4K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+4K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+4K222707IH Implant SystemSewonmedix, Inc.20231—
+4K221752StellaShinhung Mst Co., Ltd.20230—
+4K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+4K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+4K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+4K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+4K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240977DenQ Sub SLA Implant SystemDenq20240—
+5K232528Protective CapNeobiotech Co., Ltd.20240—
+5K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K231079LW Retraction CapOssvis Co., Ltd.20230—
+5K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K210039CORE1 Implant SystemCybermed, Inc.20220—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+6K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+6K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—