510(k) Report

Devices descending from K023113

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+4K151928PUR Dental Implant SystemSterngold Dental, LLC20150—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K142260NobelActiveNobel Biocare AB201599—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+4K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc.20140—
+4K141450AXIOM 2.8Anthogyr Sas201401
+4K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+4K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+4K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+4K133339Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M…Zimmer Dental, Inc.20143—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+4K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+4K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+4K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+4K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+4K113779Conelog Implant SystemAltatec GmbH201214—
+4K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+4K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+4K121334VarioecoThommen Medical AG201216—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+4K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+4K110577Osseofuse Dental Implant SystemDynamic Innovations, Inc.20114—
+4K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+4K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+4K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+4K101068Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC20100—
+4K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC2008952
+4K072570Nobelactive Multi Unit AbutmentNobel Biocare AB20071811
+4K072980Nobelperfect Conical Connection Hexagonal ImplantsNobel Biocare AB20070—
+4K072589Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Zimmer Dental, Inc.2007983
+4K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074144
+4K063718SFB and CFB Implants - 5.0 PlatformNobel Biocare AB20070—
+4K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB2006327—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+5K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+5K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+5K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+5K230103Klockner AbutmentsSoadco, S.L.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K220823Preat AbutmentsPreat Corporation202216