510(k) Report

Devices descending from K991053

426 later devices reach Astra Tech Implants - Dental System: New Fixtures (Micromacro) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+7K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+7K152555Dental Implant SystemAriabio International, Inc.20160—
+7K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+7K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+7K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+7K133362SGS Dental ImplantSgs International, Ltd.20142—
+7K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+8K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+8K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+8K220022TRATE Dental Implant SystemTrate AG20221—
+8K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+8K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+8K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+8K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+8K171532TruBase STruabutment, Inc.20187—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+8K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+8K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+8K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+8K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+9K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+9K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+9K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+9K240143JDZygoma dental implantsJdentalcare Srl20240—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—