510(k) Report

Devices descending from K022424

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+8K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+8K191152MIS Ti-base AbutmentDentsply Sirona20201—
+8K193078MIS CONNECT Conical Connection SystemDentsply Sirona20200—
+8K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+8K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+8K181932DTX Studio designNobel Biocare AB20190—
+8K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+8K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+8K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+8K180609Rodo SmilekeyRodo Medical, Inc.20180—
+8K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+8K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+8K170394Kisses MiniAchimhai Medical Corporation20170—
+8K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+8K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+8K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+8K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+8K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+8K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+8K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+8K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+8K151599iSy Implant SystemAltatec GmbH20150—
+8K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+8K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+8K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+8K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+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—
+9K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+9K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+9K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+9K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+9K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+9K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+9K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+9K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+9K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+9K221107TRUSTRgorithm Korea20230—
+9K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+9K222636ET Abutment SystemHiossen, Inc.20230—
+9K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+9K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+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—
+9K211225MIS Ti-base abutmentDentsply Sirona20210—
+9K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+9K192742Straumann Variobase CInstitut Straumann AG20211—
+9K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+9K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+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—
+9K171532TruBase STruabutment, Inc.20187—
+9K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+9K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+9K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+9K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+9K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+9K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+9K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+9K160784CAM Titanium BlanksAltatec GmbH20161—
+10K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+10K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+10K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+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—
+10K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+10K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant 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—
+10K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+10K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+10K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+10K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+10K223663SIMDA AbutmentSimda Co., Ltd.20232—
+10K222976MU SystemDentis Co., Ltd.20230—
+10K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+10K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+10K220252High Retention Attachment SystemZest Anchors, LLC20221—