510(k) Report

Devices descending from K051461

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+5K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231559Multi-Unit DAS SystemTalladium España, SL20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K232151Dynamic TiBaseTalladium España, SL20232—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K213391High Retention Attachment SystemZest Anchors, LLC20227—
+5K212664SherlockOpen Implants, LLC20212—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+5K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K243530Dynamic TiBaseTalladium España, SL20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+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—
+6K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220482SherlockOpen Implants, LLC20221—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+6K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+7K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+7K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—