510(k) Report

Devices descending from K013798

575 later devices reach Prosthetic Accessories to the Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+1K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+1K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+1K020096Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG20025161
+2K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+2K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K162299Spiral Shape Dental Implant SystemGp Implants20173—
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+2K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+2K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+2K103280Bhdental Implant SystemBhdental, Ltd.20110—
+2K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+2K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+2K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+2K071803Ards Dental ImplantsArds, Ltd.200813—
+2K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+2K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+2K033243Iti Synocta Meso AbutmentsStraumann USA2003514—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K172240SPI Dental Implant SystemMsi France20180—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+3K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+3K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+3K131701Z5MLB, Z5MLCZ-Systems AG20131—
+3K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+3K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+3K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+3K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+3K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+3K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+3K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+3K061277Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingStraumann USA2007265—
+3K062129P.0004 ImplantsInstitut Straumann AG2006434—
+3K052272Straumann Computer Aided Restoration ServiceStraumann USA2006268—
+3K041275Procera Abutment OctagonNobel Biocare Uas, Inc.200461—
+3K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004328—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K213677Bonafix 2 PlusZentek Medical, LLC20220—
+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