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
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+6K180609Rodo SmilekeyRodo Medical, Inc.20180—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+6K170394Kisses MiniAchimhai Medical Corporation20170—
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+6K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+6K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+6K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151599iSy Implant SystemAltatec GmbH20150—
+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—
+6K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+6K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+6K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+7K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+7K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K253341Custom Abutments ASMedentika GmbH20250—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251280DESS® Dental ImplantsTerrats Medical SL20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K232383iPhysio® SystemEuroteknika20250—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K221107TRUSTRgorithm Korea20230—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+7K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+7K212664SherlockOpen Implants, LLC20212—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+7K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—