510(k) Report

Devices descending from K993595

942 later devices reach Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+6K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K222707IH Implant SystemSewonmedix, Inc.20231—
+6K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+6K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K222792SNUCONE Tissue Level Implant SystemSnucone Co., Ltd.20232—
+6K221752StellaShinhung Mst Co., Ltd.20230—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+6K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+6K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+6K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+6K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+6K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K212664SherlockOpen Implants, LLC20212—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+6K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+6K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+6K201981Magicore SystemInnobiosurg Co., Ltd.20204—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K192197Magicore II SystemInnobiosurg Co., Ltd.20203—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K192263UCLA CCM AbutmentDio Corporation20204—
+6K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K190552JJ Implant SystemJj Implants20190—