510(k) Report

Devices descending from K062030

183 later devices reach US System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231079LW Retraction CapOssvis Co., Ltd.20230—
+4K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+4K222738Point implant systemPointnix Co., Ltd.20230—
+4K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+4K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+4K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+4K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K201621Magicore II SystemInnobiosurg Co., Ltd.20202—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+4K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+4K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+4K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+4K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+4K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+4K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K152559TruAbutment DSTruabutment201618—
+4K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+4K140600SB AnchorOsstem Implant Co., Ltd.20144—
+4K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+4K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+4K131165Anker Dental Implant SystemAlliance Global20131—
+4K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+4K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+4K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+5K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+5K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+5K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K223924LW Implant SystemOssvis Co., Ltd.20231—
+5K222451Save GBRDentis Co., Ltd.20230—
+5K220517IBS SystemInnobiosurg Co., Ltd.20220—
+5K210354SNUCONE Bone Level Implant SystemSnucone Co., Ltd.20220—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd.20225—
+5K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K210499Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20211—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+5K192294I DoI DO Biotech Co., Ltd.20200—
+5K192747Yxoss CBR®Reoss GmbH20200—
+5K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K190641AR_N SLA Type Implant SystemBiotem Co., Ltd.20200—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170259TruAbutment DSTruabutment201717—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K241703SD Implant SystemArum Dentistry Co., Ltd.20250—
+6K240435Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20240—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K230725NB Implant SystemArum Dentistry Co., Ltd.20231—
+6K222131NB 1 SA Implant SystemArum Dentistry Co., Ltd.20221—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K191913TruAbutment DSTruabutment, Inc.20200—
+6K172304TruAbutment DSTruabutment, Inc.20188—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+7K183106TruAbutment DSTruabutment, Inc.20207—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+9K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—