510(k) Report

Devices descending from K033922

346 later devices reach Modification to Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+1K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+1K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+1K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+1K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+1K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+1K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+1K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+1K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+1K061176Straumann Dental ImplantsInstitut Straumann AG2006148—
+2K231566ICX-Implant SystemMedentis Medical GmbH20240—
+2K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+2K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+2K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+2K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+2K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+2K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+2K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+2K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+2K140934Hiossen Implant SystemHiossen, Inc.201413—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+2K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+2K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+2K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+2K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+2K101545Genesis Implant SystemKeystone Dental2010153
+2K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+3K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+3K221752StellaShinhung Mst Co., Ltd.20230—
+3K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+3K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K212538DESS Dental ImplantsTerrats Medical SL20211—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+3K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K191201EM SA Implant SystemHiossen, Inc.20191—