510(k) Report

Devices descending from K003271

612 later devices reach Modification to Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+4K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+4K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+4K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+4K110580Narrow Connection Straumann Anatomic Ips E.Max AbutmentsStraumann USA20110—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+4K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+4K093027Straumann RC Temporary AbutmentsStraumann USA201097—
+4K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG2009169—
+4K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+4K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20082631
+4K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008179—
+4K061277Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingStraumann USA2007265—
+4K052272Straumann Computer Aided Restoration ServiceStraumann USA2006268—
+4K041275Procera Abutment OctagonNobel Biocare Uas, Inc.200461—
+4K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004328—
+5K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K230103Klockner AbutmentsSoadco, S.L.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200386Z5-BLZ-Systems AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—