510(k) Report

Devices descending from K024004

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+5K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+5K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+5K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+5K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+5K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—