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
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K172100URIS OMNI SystemTruabutment, Inc.20187—
+5K172798Straumann CARES Abutments CoCrInstitut Straumann AG20180—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+5K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+5K123638Pekkton IvoryCendres & Metaux SA20130—
+5K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+5K113606NNC Gold Abutment for BridgesStraumann USA20120—
+5K113410NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Straumann USA20121—
+5K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+5K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+5K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+5K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K090069Procera Implant Bridge OverdentureNobel Biocare AB2009313—
+5K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG2008171—
+5K082764Straumann WN Cares Titanium AbutmentInstitut Straumann AG2008171—
+5K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+5K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+5K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB200626—
+5K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB200633—
+5K053091Procera Implant Bridge ZirconiaNobel Biocare AB20066—
+5K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K232528Protective CapNeobiotech Co., Ltd.20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—