510(k) Report

Devices descending from K072624

301 later devices reach Astra Tech Implant System, New Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K123627ET Smartfit AbutmentHiossen, Inc.201321—
+4K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+5K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+5K243732Multi-Unit DAS SystemTalladium España, SL20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K243530Dynamic TiBaseTalladium España, SL20250—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+5K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K220482SherlockOpen Implants, LLC20221—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K220252High Retention Attachment SystemZest Anchors, LLC20221—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K152559TruAbutment DSTruabutment201618—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+6K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K170259TruAbutment DSTruabutment201717—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K191913TruAbutment DSTruabutment, Inc.20200—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+7K172304TruAbutment DSTruabutment, Inc.20188—
+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—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K183106TruAbutment DSTruabutment, Inc.20207—
+9K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—