510(k) Report

Devices descending from K003552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+4K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K200102MIS Dental Implant SystemDentsply Sirona20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+4K191201EM SA Implant SystemHiossen, Inc.20191—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+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—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+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—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+4K123471Etii SA Fixture SystemHiossen, Inc.201314—
+4K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+4K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+4K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+4K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+4K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+4K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+4K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+4K110337Universal Maxillary MolarOco Biomedical20121—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+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—
+4K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—