510(k) Report

Devices descending from K031719

514 later devices reach Esthetic Zirconia Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K213599SuperLineDentium Co., Ltd.20220—
+7K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+7K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+7K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+7K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+7K160786RODO Abutment SystemRodo Medical, Inc.20162—
+7K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K150295LOCATOR RTxZest Anchors, Inc.201542—
+7K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+7K142167Medentika Abutment SystemMedentika GmbH20157—
+7K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+8K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+8K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+8K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+8K180609Rodo SmilekeyRodo Medical, Inc.20180—
+8K170394Kisses MiniAchimhai Medical Corporation20170—
+8K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+8K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+9K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K253341Custom Abutments ASMedentika GmbH20250—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+9K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+9K222636ET Abutment SystemHiossen, Inc.20230—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+9K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+9K213391High Retention Attachment SystemZest Anchors, LLC20227—
+9K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+9K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+10K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+10K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+10K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+10K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+10K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+10K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+10K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+10K222976MU SystemDentis Co., Ltd.20230—
+10K220252High Retention Attachment SystemZest Anchors, LLC20221—
+10K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—