510(k) Report

Devices descending from K032158

542 later devices reach Xive Dental Implant System Multiple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+5K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+5K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+5K113606NNC Gold Abutment for BridgesStraumann USA20120—
+5K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+5K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K212664SherlockOpen Implants, LLC20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+6K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+6K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—