510(k) Report

Devices descending from K984104

1,043 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+5K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+5K242379LL Implant SystemOssvis Co., Ltd.20240—
+5K242261Accelx Implant SystemBiotech Dental, LLC20240—
+5K240383Highness Implant SystemHighness Co., Ltd.20240—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+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—
+5K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+5K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+5K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K221752StellaShinhung Mst Co., Ltd.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K222738Point implant systemPointnix Co., 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—
+5K223395Luna Dental Implant SystemShinhung Mst Co., 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—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+5K211872PiezoImplant SystemRex Implants, Inc.20220—
+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—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K201712Z5-TLZ-Systems AG20200—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200386Z5-BLZ-Systems AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+5K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+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—
+5K190243Z5-BLZ-Systems AG20202—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+5K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+5K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—