510(k) Report

Devices descending from K022009

478 later devices reach 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+4K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+4K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+4K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K213677Bonafix 2 PlusZentek Medical, LLC20220—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220823Preat AbutmentsPreat Corporation202216
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K221966Dynamic TiBaseTalladium Espana, SL20225—
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+4K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200386Z5-BLZ-Systems AG20200—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+4K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K180609Rodo SmilekeyRodo Medical, Inc.20180—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K170394Kisses MiniAchimhai Medical Corporation20170—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+4K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+4K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+4K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—