510(k) Report

Devices descending from K022009

478 later devices reach 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K243530Dynamic TiBaseTalladium España, SL20250—
+6K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K220482SherlockOpen Implants, LLC20221—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K210039CORE1 Implant SystemCybermed, Inc.20220—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+6K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+6K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+6K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+6K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+6K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—