510(k) Report

Devices descending from K013867

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+4K151757IMMEDIATELOAD Dental Implant SystemImmediateload S.A.20160—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K151588maxFit II Dental Implant SystemTaiwan Implant Technology Company, Ltd.20160—
+4K151439Atlantis IsusDentsply International, Inc.20160—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+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—
+4K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+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—
+4K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K140347Ankylos C/X Implant SystemDentsply Intl., Inc.20146—
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K131066Axiom RegAnthogyr Sas20142—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+4K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+4K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+4K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+4K120414Osseospeed PlusAstra Tech AB2012196—
+4K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+4K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K110337Universal Maxillary MolarOco Biomedical20121—
+4K113606NNC Gold Abutment for BridgesStraumann USA20120—
+4K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+4K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+4K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K081851Neoss Access AbutmentsNeoss, Ltd.20090—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+4K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+4K071803Ards Dental ImplantsArds, Ltd.200813—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—