510(k) Report

Devices descending from K954347

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+5K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220823Preat AbutmentsPreat Corporation202216
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K200102MIS Dental Implant SystemDentsply Sirona20200—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K191201EM SA Implant SystemHiossen, Inc.20191—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+5K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+5K163043Zeramex P6 Dental Implant SystemDentalpoint AG20160—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+5K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K160119NobelSpeedy GroovyNobel Biocare AB20167—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K152845Allied Biocompat Abutment for Nobel Replace InterfaceAllied Dental Solutions20160—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K141188Microdent Genius Implant SystemImplant Microdent20150—
+5K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+5K133050One Plus Implant SystemOsseofuse, Inc.20141—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+5K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+5K132881Z5CZ-Systems AG20148—
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+5K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+5K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+5K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+5K131748Osseofuse Dental Implant SystemOsseofuse, Inc.20130—
+5K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381