510(k) Report

Devices descending from K050705

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+4K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K190552JJ Implant SystemJj Implants20190—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+4K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+4K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+4K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+4K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+4K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+4K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+4K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K141450AXIOM 2.8Anthogyr Sas201401
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K123861Aidi Dental Implant SystemAidi Biomedical, LLC20130—
+4K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+4K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+4K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+4K120414Osseospeed PlusAstra Tech AB2012196—
+4K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+4K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+4K111287Astra Tech Implant SystemAstra Tech AB2011201—
+4K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+4K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+4K081806Idi Implant SystemIdi Biomedical, LLC20082—
+5K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+5K261122Mist ICImagine Milling Technologies, LLC20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K233271OsseOne Dental Implant SystemSynoross Dba Osseone20250—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+5K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl20240—
+5K240837TOV Dental Implant SystemRdj Tov Implant, Ltd.20244—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+5K221673Bonafix TiBaseZentek Medical, LLC20231—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220482SherlockOpen Implants, LLC20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—