510(k) Report

Devices descending from K974738

543 later devices reach Astra Tech Implant Dental System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K210039CORE1 Implant SystemCybermed, Inc.20220—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K193352AbutmentCADExocad GmbH20210—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+6K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+6K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+6K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K200100Abutment Design3Shape A/S20203—
+6K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193404UF (II) Bar holder abutmentDio Corporation20200—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+6K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+6K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+6K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+6K152559TruAbutment DSTruabutment201618—
+6K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+6K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+6K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+6K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+6K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+7K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+7K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+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—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240977DenQ Sub SLA Implant SystemDenq20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221107TRUSTRgorithm Korea20230—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K170259TruAbutment DSTruabutment201717—
+7K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—