510(k) Report

Devices descending from K050705

532 later devices reach Tiunite Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+3K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+3K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+3K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+3K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+3K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+3K142260NobelActiveNobel Biocare AB201599—
+3K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K133050One Plus Implant SystemOsseofuse, Inc.20141—
+3K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+3K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+3K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+3K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+3K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+3K131748Osseofuse Dental Implant SystemOsseofuse, Inc.20130—
+3K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+3K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+3K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+3K120776Abutment for Competitive Implant Nobel Active ConnectionBiomet 3i20120—
+3K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+3K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+3K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+3K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+3K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K101732Astra Tech Implant SystemAstra Tech AB2011214—
+3K102436Nobel Active 3.0Nobel Biocare AB2010203—
+3K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+3K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+3K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+3K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+3K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+3K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+3K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+3K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+3K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+3K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+3K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+3K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC2008952
+3K072980Nobelperfect Conical Connection Hexagonal ImplantsNobel Biocare AB20070—
+3K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+4K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+4K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243009Mist ICImagine Milling Technologies, LLC20251—
+4K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+4K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+4K240383Highness Implant SystemHighness Co., Ltd.20240—
+4K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+4K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+4K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+4K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+4K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+4K221381KDG AbutmentsKeystone Dental, Inc.20220—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212664SherlockOpen Implants, LLC20212—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+4K212108Dynamic TiBaseTalladium España, SL20219—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+4K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K182081JDentalCare Implant System JDIconJdentalcare Srl20201—