510(k) Report

Devices descending from K020646

630 later devices reach Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+8K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+8K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+8K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+8K220022TRATE Dental Implant SystemTrate AG20221—
+8K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+8K213599SuperLineDentium Co., Ltd.20220—
+8K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+8K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+8K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+8K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+8K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+8K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+8K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+8K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+8K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+8K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+8K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+8K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+8K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+8K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+8K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+8K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+8K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+8K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+8K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+8K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+8K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+8K173326MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd.20181—
+8K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+8K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+8K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+8K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+8K162390ET Hybrid AbutmentHiossen, Inc.20172—
+8K160786RODO Abutment SystemRodo Medical, Inc.20162—
+8K1514553Shape Abutment Designer Software3Shape A/S201610—
+8K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+8K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+8K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+8K160244VARIOuniteThommen Medical AG201615—
+8K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+8K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+8K150295LOCATOR RTxZest Anchors, Inc.201542—
+8K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+8K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+8K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+8K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+8K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+8K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+8K133991ISYAltatec GmbH20142—
+8K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+8K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+8K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+8K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+8K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+8K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+8K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+8K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+9K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+9K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd.20250—
+9K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd.20250—
+9K243278Custom AbutmentsInstitut Straumann AG202501
+9K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+9K243094Quickdent Dental Implant SystemQuickdent Devices Private, Ltd.20240—
+9K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+9K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+9K240143JDZygoma dental implantsJdentalcare Srl20240—
+9K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K233389EK Digital AbutmentsHiossen, Inc.20240—
+9K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+9K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+9K231559Multi-Unit DAS SystemTalladium España, SL20231—
+9K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+9K232151Dynamic TiBaseTalladium España, SL20232—
+9K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+9K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+9K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+9K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+9K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+9K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+9K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+9K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+9K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+9K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+9K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+9K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—