510(k) Report

Devices descending from K954347

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+6K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+6K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+6K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+6K231079LW Retraction CapOssvis Co., Ltd.20230—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K222738Point implant systemPointnix Co., Ltd.20230—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+6K211872PiezoImplant SystemRex Implants, Inc.20220—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K212664SherlockOpen Implants, LLC20212—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K201712Z5-TLZ-Systems AG20200—
+6K200386Z5-BLZ-Systems AG20200—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+6K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K190243Z5-BLZ-Systems AG20202—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+6K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+6K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+6K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+6K172100URIS OMNI SystemTruabutment, Inc.20187—
+6K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K171179BR Type Implant SystemBiotem Co., Ltd.20181—
+6K171185IR Type Implant SystemBiotem Co., Ltd.20171—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K170031Internal Octa Implant SystemEbi, Inc.20171—
+6K161177Axiom PXAnthogyr Sas20170—
+6K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+6K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K160786RODO Abutment SystemRodo Medical, Inc.20162—
+6K153521IH Implant SystemSewonmedix, Inc.201610—
+6K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+6K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+6K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+6K160244VARIOuniteThommen Medical AG201615—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K153779Abutment for BridgesAltatec GmbH20161—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151439Atlantis IsusDentsply International, Inc.20160—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K1505713i T3 Short ImplantsBiomet 3i20151—