510(k) Report

Devices descending from K080396

390 later devices reach Osseospeed Narrow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K213391High Retention Attachment SystemZest Anchors, LLC20227—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212664SherlockOpen Implants, LLC20212—
+4K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K193352AbutmentCADExocad GmbH20210—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200100Abutment Design3Shape A/S20203—
+4K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+4K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+4K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+4K191152MIS Ti-base AbutmentDentsply Sirona20201—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+4K181932DTX Studio designNobel Biocare AB20190—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+4K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+4K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+4K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K243732Multi-Unit DAS SystemTalladium España, SL20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+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—
+5K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+5K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+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—
+5K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K221107TRUSTRgorithm Korea20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K220517IBS SystemInnobiosurg Co., Ltd.20220—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K220482SherlockOpen Implants, LLC20221—
+5K220252High Retention Attachment SystemZest Anchors, LLC20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K211225MIS Ti-base abutmentDentsply Sirona20210—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—