510(k) Report

Devices descending from K041492

360 later devices reach Astra Tech Implants - Dental System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K220252High Retention Attachment SystemZest Anchors, LLC20221—
+7K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+8K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+9K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+9K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+9K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+9K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+10K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+11K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—