510(k) Report

Devices descending from K063861

202 later devices reach GS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+1K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+1K101890Ball Abutment SystemMegagen Co., Ltd.20110—
+1K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+1K081575HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2008129—
+1K080744HG II Fixture SystemOsstem Implant Co., Ltd.2008112—
+1K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+1K073465US/GS Ultra Wide SystemOsstem Implant Co., Ltd.200890—
+1K073247US/SS/GS SystemOsstem Implant Co., Ltd.2008141—
+1K072896GS Fixture SystemOsstem Implant Co., Ltd.200715—
+2K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+2K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+2K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+2K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+2K231429S-Plant Dental Implant SystemIdis 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—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+2K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+2K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+2K153521IH Implant SystemSewonmedix, Inc.201610—
+2K152520Magicore SystemInnobiosurg Co., Ltd.20167—
+2K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+2K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+2K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd.201254—
+2K121047Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd.201214—
+2K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+2K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+2K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+2K111120CSM Submerged-R Implant SystemCsm Implant20118—
+2K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+2K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+2K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+2K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2010111—
+2K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+2K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc.201038—
+2K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+2K082843Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd.20091—
+2K090237HG II Fixture SystemHiossen, Inc.200938—
+2K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+2K082213GS Iii Fixture SystemOsstem Implant Co., Ltd.2008110—
+3K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+3K251434Healing Abutment SystemOsstem Implant 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—
+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—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+3K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+3K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+3K222707IH Implant SystemSewonmedix, Inc.20231—
+3K221752StellaShinhung Mst Co., Ltd.20230—
+3K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+3K222976MU SystemDentis Co., Ltd.20230—
+3K201981Magicore SystemInnobiosurg Co., Ltd.20204—
+3K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+3K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+3K192197Magicore II SystemInnobiosurg Co., Ltd.20203—
+3K192263UCLA CCM AbutmentDio Corporation20204—
+3K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+3K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+3K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+3K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+3K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+3K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+3K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+3K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+3K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+3K150060J2A Dental Implant System, J2C Dental Implant SystemKj Meditech Co., Ltd.20152—
+3K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K140052J2I Implant SystemKj Meditech Co., Ltd.20140—
+3K140051KJ External Implant SystemKj Meditech Co., Ltd.20140—
+3K140600SB AnchorOsstem Implant Co., Ltd.20144—
+3K132144KeratorLK Consulting Group USA, Inc.20140—
+3K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+3K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+3K131682UD Implant SystemMedimecca Co., Ltd.20135—
+3K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+3K123471Etii SA Fixture SystemHiossen, Inc.201314—
+3K123627ET Smartfit AbutmentHiossen, Inc.201321—
+3K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+3K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+3K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—