510(k) Report

Devices descending from K023113

689 later devices reach Replace Tiunite Endosseous Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K260940BellaTek BarsZimVie US Corp, LLC20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd.20250—
+8K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd.20250—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K243094Quickdent Dental Implant SystemQuickdent Devices Private, Ltd.20240—
+8K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+8K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+8K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+8K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+8K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K201842TruBase STruabutment, Inc.20210—
+8K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+8K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+8K193078MIS CONNECT Conical Connection SystemDentsply Sirona20200—
+8K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+8K180609Rodo SmilekeyRodo Medical, Inc.20180—
+8K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+8K170394Kisses MiniAchimhai Medical Corporation20170—
+8K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+8K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+8K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+9K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+9K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+9K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+9K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+9K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+9K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+9K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+9K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+9K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+9K222636ET Abutment SystemHiossen, Inc.20230—
+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—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K193404UF (II) Bar holder abutmentDio Corporation20200—
+9K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+9K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+10K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+10K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+10K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+10K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+10K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+10K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+10K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+10K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+10K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+10K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+10K222976MU SystemDentis Co., Ltd.20230—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+10K220252High Retention Attachment SystemZest Anchors, LLC20221—
+11K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+11K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+11K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+11K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+12K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+13K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+14K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—