510(k) Report

Devices descending from K962845

644 later devices reach Replace HA Coated Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+8K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+8K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+8K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+8K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+8K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+8K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+8K240383Highness Implant SystemHighness Co., Ltd.20240—
+8K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+8K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+8K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+8K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+8K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+8K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+8K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+8K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221381KDG AbutmentsKeystone Dental, Inc.20220—
+8K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+8K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+8K212664SherlockOpen Implants, LLC20212—
+8K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+8K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+8K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+8K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+8K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+8K200355Duranext AbutmentsElegant Dental Corp.20200—
+8K182081JDentalCare Implant System JDIconJdentalcare Srl20201—
+8K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+8K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—
+8K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+8K191123Multi-unit AbutmentsMedentika GmbH202011—
+8K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+8K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+8K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+8K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+8K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+8K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+8K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+8K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+8K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+8K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+8K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+8K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+8K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+8K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+8K152555Dental Implant SystemAriabio International, Inc.20160—
+8K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+8K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+8K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+8K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+8K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+8K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+8K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+8K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+8K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+8K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+8K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+8K123861Aidi Dental Implant SystemAidi Biomedical, LLC20130—
+8K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+8K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+8K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+8K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+8K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+8K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+8K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+8K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+8K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+8K120414Osseospeed PlusAstra Tech AB2012196—
+8K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+8K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+8K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+8K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+8K111287Astra Tech Implant SystemAstra Tech AB2011201—
+8K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+8K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+8K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+8K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+9K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—