510(k) Report

Devices descending from K002374

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+6K140934Hiossen Implant SystemHiossen, Inc.201413—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+6K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+6K123627ET Smartfit AbutmentHiossen, Inc.201321—
+6K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+6K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+6K121117NDX AbutmentsNational Dentex Corp20120—
+6K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+6K121047Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd.201214—
+6K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+6K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+6K111120CSM Submerged-R Implant SystemCsm Implant20118—
+6K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+6K091208GS Iii SystemOsstem Implant Co., Ltd.201028—
+6K090237HG II Fixture SystemHiossen, Inc.200938—
+6K082213GS Iii Fixture SystemOsstem Implant Co., Ltd.2008110—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+7K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K240977DenQ Sub SLA Implant SystemDenq20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K232528Protective CapNeobiotech Co., Ltd.20240—
+7K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+7K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+7K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+7K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+7K232546Meta G UCLA AbutmentCowellmedi Co., Ltd.20230—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+7K231079LW Retraction CapOssvis Co., Ltd.20230—
+7K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222738Point implant systemPointnix Co., Ltd.20230—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+7K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+7K201621Magicore II SystemInnobiosurg Co., Ltd.20202—
+7K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+7K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+7K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+7K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+7K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+7K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+7K152559TruAbutment DSTruabutment201618—
+7K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+7K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+7K150060J2A Dental Implant System, J2C Dental Implant SystemKj Meditech Co., Ltd.20152—
+7K140600SB AnchorOsstem Implant Co., Ltd.20144—
+7K132144KeratorLK Consulting Group USA, Inc.20140—
+7K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+7K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+7K131682UD Implant SystemMedimecca Co., Ltd.20135—
+7K131165Anker Dental Implant SystemAlliance Global20131—
+7K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+7K123471Etii SA Fixture SystemHiossen, Inc.201314—
+7K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+7K093352HG Iii Fixture SystemHiossen, Inc.2009105—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+8K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—