510(k) Report

Devices descending from K062129

434 later devices reach P.0004 Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+3K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+3K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+3K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+3K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+3K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+3K123638Pekkton IvoryCendres & Metaux SA20130—
+3K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+3K113606NNC Gold Abutment for BridgesStraumann USA20120—
+3K113410NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Straumann USA20121—
+3K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+3K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+3K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+3K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+3K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG2008171—
+3K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+4K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+4K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243009Mist ICImagine Milling Technologies, LLC20251—
+4K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+4K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+4K232528Protective CapNeobiotech Co., Ltd.20240—
+4K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+4K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+4K231079LW Retraction CapOssvis Co., Ltd.20230—
+4K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+4K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+4K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+4K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+4K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+4K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212664SherlockOpen Implants, LLC20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K212108Dynamic TiBaseTalladium España, SL20219—
+4K211225MIS Ti-base abutmentDentsply Sirona20210—
+4K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—