510(k) Report

Devices descending from K023113

689 later devices reach Replace Tiunite Endosseous Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+5K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+5K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+5K103280Bhdental Implant SystemBhdental, Ltd.20110—
+5K101732Astra Tech Implant SystemAstra Tech AB2011214—
+5K102436Nobel Active 3.0Nobel Biocare AB2010203—
+5K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+5K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+5K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+5K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+5K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+5K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+5K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+5K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+5K081806Idi Implant SystemIdi Biomedical, LLC20082—
+5K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+5K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+5K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+6K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221381KDG AbutmentsKeystone Dental, Inc.20220—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+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—
+6K193352AbutmentCADExocad GmbH20210—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K200100Abutment Design3Shape A/S20203—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K182081JDentalCare Implant System JDIconJdentalcare Srl20201—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+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—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+6K171532TruBase STruabutment, Inc.20187—
+6K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—