510(k) Report

Devices descending from K041295

368 later devices reach RN Synocta Ucla Gold Abutment for the Straumann Dental Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K232528Protective CapNeobiotech Co., Ltd.20240—
+6K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+6K231079LW Retraction CapOssvis Co., Ltd.20230—
+6K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K212538DESS Dental ImplantsTerrats Medical SL20211—
+6K212664SherlockOpen Implants, LLC20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K171795Thommen Implant SystemThommen Medical AG20170—
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+6K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K153521IH Implant SystemSewonmedix, Inc.201610—
+6K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+6K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+6K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K251280DESS® Dental ImplantsTerrats Medical SL20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+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—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—