510(k) Report

Devices descending from K003552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K082749Omni-TightBasic Dental Implant Systems, Inc.20080—
+4K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+4K071803Ards Dental ImplantsArds, Ltd.200813—
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+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—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+5K232383iPhysio® SystemEuroteknika20250—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+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—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.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—
+5K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+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—
+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—
+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—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220823Preat AbutmentsPreat Corporation202216
+5K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+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—
+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—
+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—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+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—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+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—
+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—
+5K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—