510(k) Report

Devices descending from K991947

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH20201—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K160244VARIOuniteThommen Medical AG201615—
+4K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+4K151439Atlantis IsusDentsply International, Inc.20160—
+4K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+4K150295LOCATOR RTxZest Anchors, Inc.201542—
+4K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+4K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+4K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+4K141457Dentium Implantium and Superline AbutmentsDentium Co., Ltd.20146—
+4K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K133991ISYAltatec GmbH20142—
+4K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+4K132881Z5CZ-Systems AG20148—
+4K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+4K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+4K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+4K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+4K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+4K123627ET Smartfit AbutmentHiossen, Inc.201321—
+4K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+4K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+4K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+4K113779Conelog Implant SystemAltatec GmbH201214—
+4K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+4K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+4K121334VarioecoThommen Medical AG201216—
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc.201201
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+4K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+4K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc.2010200—
+4K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+4K091920Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…Astra Tech, Inc.200940—
+4K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+4K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+4K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+4K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+4K063734Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc.200738—
+4K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.200671—
+4K053450Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc.20062—
+5K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+5K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—