510(k) Report

Devices descending from K041661

622 later devices reach Nobel Biocare Endosseous Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K221381KDG AbutmentsKeystone Dental, Inc.20220—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212664SherlockOpen Implants, LLC20212—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+5K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K182081JDentalCare Implant System JDIconJdentalcare Srl20201—
+5K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+5K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K191123Multi-unit AbutmentsMedentika GmbH202011—
+5K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+5K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+5K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+5K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+5K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+5K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+5K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+5K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+5K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K123861Aidi Dental Implant SystemAidi Biomedical, LLC20130—
+5K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+5K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+5K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+5K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+5K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+5K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+5K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+5K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+5K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+5K111287Astra Tech Implant SystemAstra Tech AB2011201—
+5K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+5K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+6K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+6K233271OsseOne Dental Implant SystemSynoross Dba Osseone20250—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl20240—
+6K240837TOV Dental Implant SystemRdj Tov Implant, Ltd.20244—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+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—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+6K220482SherlockOpen Implants, LLC20221—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—