510(k) Report

Devices descending from K021318

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K193352AbutmentCADExocad GmbH20210—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K200100Abutment Design3Shape A/S20203—
+4K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+4K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+4K191152MIS Ti-base AbutmentDentsply Sirona20201—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K181932DTX Studio designNobel Biocare AB20190—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K161177Axiom PXAnthogyr Sas20170—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+4K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K160244VARIOuniteThommen Medical AG201615—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K150295LOCATOR RTxZest Anchors, Inc.201542—
+4K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K141450AXIOM 2.8Anthogyr Sas201401
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K113779Conelog Implant SystemAltatec GmbH201214—
+4K121334VarioecoThommen Medical AG201216—
+4K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+4K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+4K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+4K071803Ards Dental ImplantsArds, Ltd.200813—
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—