510(k) Report

Devices descending from K022859

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K123638Pekkton IvoryCendres & Metaux SA20130—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+5K113606NNC Gold Abutment for BridgesStraumann USA20120—
+5K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K212664SherlockOpen Implants, LLC20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K193352AbutmentCADExocad GmbH20210—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+6K200100Abutment Design3Shape A/S20203—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+6K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+6K152555Dental Implant SystemAriabio International, Inc.20160—
+6K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+6K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+6K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+6K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+6K133362SGS Dental ImplantSgs International, Ltd.20142—
+6K140934Hiossen Implant SystemHiossen, Inc.201413—
+6K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+6K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—