510(k) Report

Devices descending from K991947

565 later devices reach 3I Ceramic Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K152559TruAbutment DSTruabutment201618—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K142260NobelActiveNobel Biocare AB201599—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+5K133362SGS Dental ImplantSgs International, Ltd.20142—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+5K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+5K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+5K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+5K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+5K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+5K103280Bhdental Implant SystemBhdental, Ltd.20110—
+5K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+5K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+5K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+5K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+5K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+5K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+5K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+6K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K212538DESS Dental ImplantsTerrats Medical SL20211—
+6K212664SherlockOpen Implants, LLC20212—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K193352AbutmentCADExocad GmbH20210—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—