510(k) Report

Devices descending from K023113

689 later devices reach Replace Tiunite Endosseous Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213599SuperLineDentium Co., Ltd.20220—
+1K212538DESS Dental ImplantsTerrats Medical SL20211—
+1K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+1K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+1K112787KeratorKj Meditech Co., Ltd.20123—
+1K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+1K110565Abutments for Competitive Implant Systems-Nobel ReplaceBiomet 3i, Inc.201110—
+1K103790Ace Trimark Tricam Dental ImplantAce Surgical Supply Company, Inc.20110—
+1K091920Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…Astra Tech, Inc.200940—
+1K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+1K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+1K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.200671—
+1K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+1K053654Atlantis Abutment for Nobel Replace InterfaceAtlantis Components, Inc.200612—
+1K050208Friadent EstheticapDentsply International20053—
+1K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004622—
+1K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004328—
+2K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+2K251280DESS® Dental ImplantsTerrats Medical SL20250—
+2K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+2K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+2K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+2K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+2K152845Allied Biocompat Abutment for Nobel Replace InterfaceAllied Dental Solutions20160—
+2K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+2K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+2K132881Z5CZ-Systems AG20148—
+2K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+2K132144KeratorLK Consulting Group USA, Inc.20140—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+2K112730Abutment for Competitive Implant Straumann Bone Level ConnectionBiomet 3i201292
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+2K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+2K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+2K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+2K090069Procera Implant Bridge OverdentureNobel Biocare AB2009313—
+2K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+2K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+2K073458BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl20082—
+2K073073Ankylos Temporary Abutment BalanceDentsply International, Inc.20080—
+2K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+2K053099Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc.20061—
+2K053091Procera Implant Bridge ZirconiaNobel Biocare AB20066—
+2K050406Nobelspeedy ImplantsNobel Biocare AB2005234—
+2K050705Tiunite ImplantsNobel Biocare AB20055321
+2K050258Groovy ImplantsNobel Biocare AB200551128
+2K040757Sic ProSic Invent AG20052—
+2K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K201712Z5-TLZ-Systems AG20200—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K200386Z5-BLZ-Systems AG20200—
+3K200355Duranext AbutmentsElegant Dental Corp.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K190243Z5-BLZ-Systems AG20202—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K181037DIO CAD/CAM AbutmentDio Corporation20187—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K160119NobelSpeedy GroovyNobel Biocare AB20167—
+3K151439Atlantis IsusDentsply International, Inc.20160—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+3K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+3K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+3K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+3K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+3K131066Axiom RegAnthogyr Sas20142—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+3K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+3K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+3K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+3K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+3K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+3K123386Periotype X-PertClinical House Europe GmbH20131—
+3K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+3K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+3K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+3K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122—
+3K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+3K120776Abutment for Competitive Implant Nobel Active ConnectionBiomet 3i20120—
+3K113606NNC Gold Abutment for BridgesStraumann USA20120—
+3K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+3K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+3K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—