510(k) Report

Devices descending from K013798

575 later devices reach Prosthetic Accessories to the Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200386Z5-BLZ-Systems AG20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190048UF (II) Anatomic abutmentDio Corporation20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K150899Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC201511—
+4K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH20158—
+4K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+4K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+4K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K091701Straumann Modified Dental AbutmentInstitut Straumann AG200911—
+4K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG2009169—
+4K090069Procera Implant Bridge OverdentureNobel Biocare AB2009313—
+4K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+4K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG2008171—
+4K082764Straumann WN Cares Titanium AbutmentInstitut Straumann AG2008171—
+4K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+4K071888Straumann P.004 RC Gold Abutment for BridgesStraumann USA20071—
+4K072679P.004 AbutmentsInstitut Straumann AG2007279—
+4K072497P.004 NC Gold Abutment for CrownsInstitut Straumann AG2007224—
+4K071919P.004 AbutmentsStraumann USA (On Behalf of Institut Straumann Ag)20070—
+4K071357P.004 NC Anatomic AbutmentsInstitut Straumann AG2007114—
+4K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc.2007283—
+4K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA20072641
+4K070549Straumann P.004 RC Gold AbutmentInstitut Straumann AG2007225—
+4K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG2007205—
+4K071585P.004 Healing Abutments and Closure ScrewsStraumann USA20072331
+4K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB200626—
+4K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB200633—
+4K053091Procera Implant Bridge ZirconiaNobel Biocare AB20066—
+4K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K230103Klockner AbutmentsSoadco, S.L.20230—