510(k) Report

Devices descending from K023113

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+3K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+3K093615Spi Dental Implant, ElementThommen Medical AG20101—
+3K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+3K091848Nobel/Procera Implant BridgeNobel Biocare AB20091—
+3K091878Osseolink Dental Implant SystemGlobal Implant Solutions, LLC20090—
+3K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+3K091904Nobelprocera ZI AbutmentNobel Biocare AB200935—
+3K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+3K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+3K081101Spectra-System Abutments 2008Implant Direct, LLC200911—
+3K081128Molar ImplantNobel Biocare AB20080—
+3K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+3K070184Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentOspol AB20081—
+3K062936Nobelperfect Conical ConnectionNobel Biocare AB20061—
+3K062566Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC200610927
+3K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Zimmer Dental, Inc.20061221
+3K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+3K061003SFB & CFB ImplantsNobel Biocare AB2006507—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+4K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+4K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+4K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+4K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K161177Axiom PXAnthogyr Sas20170—
+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
+4K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—