510(k) Report

Devices descending from K033922

346 later devices reach Modification to Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+4K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K193335SherlockOpen Implants, LLC20203—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+4K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K212664SherlockOpen Implants, LLC20212—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—