510(k) Report

Devices descending from K013867

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K212664SherlockOpen Implants, LLC20212—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K191123Multi-unit AbutmentsMedentika GmbH202011—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+7K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+7K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+8K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+8K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+9K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+9K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+10K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+10K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+11K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+12K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—