510(k) Report

Devices descending from K032158

542 later devices reach Xive Dental Implant System Multiple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223663SIMDA AbutmentSimda Co., Ltd.20232—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230103Klockner AbutmentsSoadco, S.L.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200386Z5-BLZ-Systems AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K171532TruBase STruabutment, Inc.20187—
+5K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—