510(k) Report

Devices descending from K980549

601 later devices reach Osseotite Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+5K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+6K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+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—
+6K242261Accelx Implant SystemBiotech Dental, LLC20240—
+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—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+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—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+6K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+6K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+6K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+6K1514553Shape Abutment Designer Software3Shape A/S201610—
+6K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+6K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemPrismatik Dentalcraft, Inc.20150—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+6K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+6K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+6K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+6K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+6K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+6K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+6K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+6K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+6K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+7K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+7K240383Highness Implant SystemHighness Co., Ltd.20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+7K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K193352AbutmentCADExocad GmbH20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K200100Abutment Design3Shape A/S20203—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+7K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+7K191152MIS Ti-base AbutmentDentsply Sirona20201—