510(k) Report

Devices descending from K012757

535 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+3K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K171795Thommen Implant SystemThommen Medical AG20170—
+3K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+3K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+3K162299Spiral Shape Dental Implant SystemGp Implants20173—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+3K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+3K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+3K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+3K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+3K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+3K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+3K150899Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC201511—
+3K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+3K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+3K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+3K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+3K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+3K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+3K133991ISYAltatec GmbH20142—
+3K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+3K132214Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Hager& Meisinger GmbH20149—
+3K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+3K132144KeratorLK Consulting Group USA, Inc.20140—
+3K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+3K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+3K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+3K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+3K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+3K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+3K110580Narrow Connection Straumann Anatomic Ips E.Max AbutmentsStraumann USA20110—
+3K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+3K093027Straumann RC Temporary AbutmentsStraumann USA201097—
+3K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG2009169—
+3K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+3K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+3K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+3K071803Ards Dental ImplantsArds, Ltd.200813—
+3K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20082631
+3K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008179—
+3K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+3K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+4K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+4K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+4K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—