510(k) Report

Devices descending from K012757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+4K230103Klockner AbutmentsSoadco, S.L.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220823Preat AbutmentsPreat Corporation202216
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+4K191152MIS Ti-base AbutmentDentsply Sirona20201—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+4K193335SherlockOpen Implants, LLC20203—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+4K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K172240SPI Dental Implant SystemMsi France20180—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K172798Straumann CARES Abutments CoCrInstitut Straumann AG20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+4K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+4K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+4K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+4K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+4K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+4K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+4K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+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—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+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—