510(k) Report

Devices descending from K050705

532 later devices reach Tiunite Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193078MIS CONNECT Conical Connection SystemDentsply Sirona20200—
+6K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+6K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+6K180609Rodo SmilekeyRodo Medical, Inc.20180—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+6K170394Kisses MiniAchimhai Medical Corporation20170—
+6K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+6K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+6K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+7K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+7K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+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—
+7K221107TRUSTRgorithm Korea20230—
+7K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K193404UF (II) Bar holder abutmentDio Corporation20200—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+8K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—