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
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+5K222142BR SLA Type Implant SystemBiotem Co., Ltd.20230—
+5K222144IR SLA Type Implant SystemBiotem Co., Ltd.20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K222636ET Abutment SystemHiossen, Inc.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—
+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—
+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—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.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—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200386Z5-BLZ-Systems AG20200—
+5K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K193335SherlockOpen Implants, LLC20203—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K190837Internal Hex Implant SystemEbi, Inc.20200—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181137IT-III active SystemNeobiotech Co., Ltd.20183—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K161177Axiom PXAnthogyr Sas20170—
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+5K153521IH Implant SystemSewonmedix, Inc.201610—
+5K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K152520Magicore SystemInnobiosurg Co., Ltd.20167—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K141450AXIOM 2.8Anthogyr Sas201401
+5K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+5K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+5K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K131066Axiom RegAnthogyr Sas20142—
+5K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+5K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+5K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+5K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+5K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—