510(k) Report

Devices descending from K013867

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200386Z5-BLZ-Systems AG20200—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+6K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193335SherlockOpen Implants, LLC20203—
+6K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K171532TruBase STruabutment, Inc.20187—
+6K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K180609Rodo SmilekeyRodo Medical, Inc.20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K170394Kisses MiniAchimhai Medical Corporation20170—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K153779Abutment for BridgesAltatec GmbH20161—
+6K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+6K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+6K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+6K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+6K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—