510(k) Report

Devices descending from K954347

1,047 later devices reach 3I Standard Threaded Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+8K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+8K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+8K111120CSM Submerged-R Implant SystemCsm Implant20118—
+8K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+8K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+8K101732Astra Tech Implant SystemAstra Tech AB2011214—
+8K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+8K102436Nobel Active 3.0Nobel Biocare AB2010203—
+8K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+8K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+8K091208GS Iii SystemOsstem Implant Co., Ltd.201028—
+8K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+8K090237HG II Fixture SystemHiossen, Inc.200938—
+8K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+8K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+8K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+8K081806Idi Implant SystemIdi Biomedical, LLC20082—
+8K082213GS Iii Fixture SystemOsstem Implant Co., Ltd.2008110—
+8K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+8K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+9K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+9K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+9K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+9K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+9K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+9K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+9K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+9K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+9K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232546Meta G UCLA AbutmentCowellmedi Co., Ltd.20230—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K221107TRUSTRgorithm Korea20230—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+9K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+9K221381KDG AbutmentsKeystone Dental, Inc.20220—
+9K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+9K220252High Retention Attachment SystemZest Anchors, LLC20221—
+9K211225MIS Ti-base abutmentDentsply Sirona20210—
+9K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+9K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+9K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+9K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+9K201621Magicore II SystemInnobiosurg Co., Ltd.20202—
+9K182081JDentalCare Implant System JDIconJdentalcare Srl20201—
+9K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+9K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+9K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+9K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+9K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+9K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+9K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+9K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+9K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+9K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+9K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+9K152559TruAbutment DSTruabutment201618—
+9K150060J2A Dental Implant System, J2C Dental Implant SystemKj Meditech Co., Ltd.20152—
+9K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+9K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+9K140600SB AnchorOsstem Implant Co., Ltd.20144—
+9K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+9K123861Aidi Dental Implant SystemAidi Biomedical, LLC20130—
+9K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+9K131682UD Implant SystemMedimecca Co., Ltd.20135—
+9K131165Anker Dental Implant SystemAlliance Global20131—
+9K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+9K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+9K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+9K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+9K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+9K111287Astra Tech Implant SystemAstra Tech AB2011201—
+9K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+9K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+9K093352HG Iii Fixture SystemHiossen, Inc.2009105—
+10K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+10K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+10K233271OsseOne Dental Implant SystemSynoross Dba Osseone20250—
+10K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+10K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl20240—
+10K240837TOV Dental Implant SystemRdj Tov Implant, Ltd.20244—
+10K241032BellaTek BarsBiomet 3i, LLC20241—
+10K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+10K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+10K223924LW Implant SystemOssvis Co., Ltd.20231—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K222451Save GBRDentis Co., Ltd.20230—