510(k) Report

Devices descending from K073465

90 later devices reach US/GS Ultra Wide System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc.201038—
+1K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+1K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+1K082843Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd.20091—
+2K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+2K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+2K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+2K111120CSM Submerged-R Implant SystemCsm Implant20118—
+2K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+2K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+2K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+2K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+3K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+3K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+3K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+3K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+3K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+3K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K140600SB AnchorOsstem Implant Co., Ltd.20144—
+3K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+3K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+3K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+3K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+4K223924LW Implant SystemOssvis Co., Ltd.20231—
+4K222738Point implant systemPointnix Co., Ltd.20230—
+4K222451Save GBRDentis Co., Ltd.20230—
+4K220517IBS SystemInnobiosurg Co., Ltd.20220—
+4K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+4K210354SNUCONE Bone Level Implant SystemSnucone Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd.20225—
+4K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K210499Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20211—
+4K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+4K192294I DoI DO Biotech Co., Ltd.20200—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K192747Yxoss CBR®Reoss GmbH20200—
+4K190641AR_N SLA Type Implant SystemBiotem Co., Ltd.20200—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+4K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+5K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K241703SD Implant SystemArum Dentistry Co., Ltd.20250—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K240435Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20240—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K230725NB Implant SystemArum Dentistry Co., Ltd.20231—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K222131NB 1 SA Implant SystemArum Dentistry Co., Ltd.20221—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+5K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—