510(k) Report

Devices descending from K022859

520 later devices reach Abutment and Prosthetic Accessories to the Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+3K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+3K121117NDX AbutmentsNational Dentex Corp20120—
+3K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+3K120414Osseospeed PlusAstra Tech AB2012196—
+3K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+3K102804Spi Titanium Base for Cad/CamThommen Medical AG201183—
+3K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+3K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20082631
+3K072497P.004 NC Gold Abutment for CrownsInstitut Straumann AG2007224—
+3K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc.2007283—
+3K053099Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc.20061—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+4K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.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—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+4K160244VARIOuniteThommen Medical AG201615—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K150295LOCATOR RTxZest Anchors, Inc.201542—
+4K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+4K150250SternSnap Angled AttachmentSterngold Dental, LLC20150—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K133991ISYAltatec GmbH20142—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+4K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+4K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+4K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451