510(k) Report

Devices descending from K031719

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+3K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+3K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+3K141457Dentium Implantium and Superline AbutmentsDentium Co., Ltd.20146—
+3K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+3K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+3K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+3K132881Z5CZ-Systems AG20148—
+3K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+3K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+3K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+3K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+3K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+3K113779Conelog Implant SystemAltatec GmbH201214—
+3K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+3K121334VarioecoThommen Medical AG201216—
+3K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc.201201
+3K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+3K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+3K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+3K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+3K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+3K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc.2010200—
+3K091920Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…Astra Tech, Inc.200940—
+3K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+3K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+3K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+3K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+3K063734Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc.200738—
+3K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.200671—
+3K053450Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc.20062—
+4K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+4K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K201712Z5-TLZ-Systems AG20200—
+4K200386Z5-BLZ-Systems AG20200—
+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—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K190243Z5-BLZ-Systems AG20202—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+4K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—