510(k) Report

Devices descending from K031719

514 later devices reach Esthetic Zirconia Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160244VARIOuniteThommen Medical AG201615—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153779Abutment for BridgesAltatec GmbH20161—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+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—
+4K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+4K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+4K142260NobelActiveNobel Biocare AB201599—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+4K133991ISYAltatec GmbH20142—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+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—
+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—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+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—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K200100Abutment Design3Shape A/S20203—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193335SherlockOpen Implants, LLC20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190552JJ Implant SystemJj Implants20190—
+5K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+5K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K181932DTX Studio designNobel Biocare AB20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+5K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—