510(k) Report

Devices descending from K023113

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+6K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+6K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+6K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+6K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+6K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+6K123861Aidi Dental Implant SystemAidi Biomedical, LLC20130—
+6K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+6K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+6K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+6K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+6K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+6K120414Osseospeed PlusAstra Tech AB2012196—
+6K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+6K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+6K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+6K111287Astra Tech Implant SystemAstra Tech AB2011201—
+6K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+6K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K233271OsseOne Dental Implant SystemSynoross Dba Osseone20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl20240—
+7K240837TOV Dental Implant SystemRdj Tov Implant, Ltd.20244—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K241032BellaTek BarsBiomet 3i, LLC20241—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K221107TRUSTRgorithm Korea20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+7K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+7K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+7K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+7K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+7K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+7K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+7K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+7K173326MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd.20181—
+7K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+7K160786RODO Abutment SystemRodo Medical, Inc.20162—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+7K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+7K150295LOCATOR RTxZest Anchors, Inc.201542—
+7K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+7K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+7K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+7K121810Osseospeed Angled Abutment EVAstra Tech AB20138—