510(k) Report

Devices descending from K030007

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+4K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+4K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+4K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+4K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+4K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+4K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+4K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+4K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+4K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+5K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+5K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+5K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+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—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+5K232528Protective CapNeobiotech Co., Ltd.20240—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K231079LW Retraction CapOssvis Co., Ltd.20230—
+5K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+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—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K200386Z5-BLZ-Systems AG20200—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—