510(k) Report

Devices descending from K080396

390 later devices reach Osseospeed Narrow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+9K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+9K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+10K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—