510(k) Report

Devices descending from K032263

476 later devices reach 3I Patient-Specific Dental Abutment and Overdenture Bar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+4K190243Z5-BLZ-Systems AG20202—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+4K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+4K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K160244VARIOuniteThommen Medical AG201615—
+4K153779Abutment for BridgesAltatec GmbH20161—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K142260NobelActiveNobel Biocare AB201599—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+4K133991ISYAltatec GmbH20142—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+4K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+4K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+4K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+4K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+4K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+4K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+5K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K193352AbutmentCADExocad GmbH20210—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200100Abutment Design3Shape A/S20203—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—