510(k) Report

Devices descending from K003552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+1K073116Ebi Internal Implant SystemEbi, Inc.20083—
+1K030007Iti Dental Implant SystemStraumann USA2003570—
+2K170031Internal Octa Implant SystemEbi, Inc.20171—
+2K142426EBI External Implant SystemEbi, Inc.20150—
+2K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+2K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+2K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+2K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+2K090709Cortex Dental Implant SystemCortex Dental Implants Industries, Ltd.20090—
+2K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+2K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+2K061176Straumann Dental ImplantsInstitut Straumann AG2006148—
+2K042971Titan Dental Implant SystemTitan Implants, Inc.20050—
+2K033984Straumann Dental Implant SystemInstitut Straumann AG2004376—
+2K040807Mis Dental Implant SystemMis - Implant Technologies, Ltd.2004218—
+2K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432—
+2K034014Spi Contact Dental ImplantThommen Medical AG20043—
+2K033922Modification to Iti Dental Implant SystemInstitut Straumann AG20043461
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+3K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+3K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+3K190837Internal Hex Implant SystemEbi, Inc.20200—
+3K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K173575OsteoReady Dental Implant SystemOsteoready, LLC20180—
+3K180598UNIQA Dental Implants SystemUniqa Dental, Ltd.20181—
+3K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K170131TAV Medical Dental Implants SystemTav Medical, Ltd.20181—
+3K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+3K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K162853Bonafix TWO - Dental Implant SystemBonafix Surgical and Dental Implants20170—
+3K161593GMI Frontier Dental Implant SystemIlerimplant S.L20170—
+3K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+3K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+3K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+3K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+3K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+3K142167Medentika Abutment SystemMedentika GmbH20157—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+3K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+3K112787KeratorKj Meditech Co., Ltd.20123—
+3K112162Conical Connection ImplantsMis Implants Technologies, Ltd.20122—
+3K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+3K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K093749GC Aadva Implant SystemGC America, Inc.20100—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+3K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+3K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+3K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc.20100—
+3K093615Spi Dental Implant, ElementThommen Medical AG20101—
+3K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+3K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+3K082651Endosseous Dental Implant SystemSouthern Implants, Inc.200814—
+3K072425Jne Implant SystemGC America, Inc.20081—
+3K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+3K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+3K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+3K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+3K061323Modification to Reliadent Dental Implant SystemBioinfera, Inc.20072—
+3K070022Mistral - One Stage Screw-Type Dental Implant, Model MF9Mis Implants Technologies, Ltd.20072—
+3K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+3K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+3K053088Slactive ImplantsInstitut Straumann AG2006295—
+3K052490Endosseous Dental Implant SystemNorthern Implants, LLC200531—
+3K043428Reliadent Dental Implant SystemBioinfera, Inc.20052—
+3K051502Spi Dental ImplantThommen Medical AG20052—
+3K040757Sic ProSic Invent AG20052—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—