510(k) Report

Devices descending from K013798

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K232528Protective CapNeobiotech Co., Ltd.20240—
+7K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+7K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K231079LW Retraction CapOssvis Co., Ltd.20230—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+7K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+7K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+7K212664SherlockOpen Implants, LLC20212—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+7K201712Z5-TLZ-Systems AG20200—
+7K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K191123Multi-unit AbutmentsMedentika GmbH202011—
+7K190243Z5-BLZ-Systems AG20202—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+7K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K171795Thommen Implant SystemThommen Medical AG20170—
+7K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+7K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+7K161435Temporary Snap AbutmentNobel Biocare AB201601
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+7K153521IH Implant SystemSewonmedix, Inc.201610—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K1514553Shape Abutment Designer Software3Shape A/S201610—
+7K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+7K160244VARIOuniteThommen Medical AG201615—
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K153779Abutment for BridgesAltatec GmbH20161—
+7K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+7K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+7K142260NobelActiveNobel Biocare AB201599—
+7K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+7K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+7K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+8K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+8K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222707IH Implant SystemSewonmedix, Inc.20231—