510(k) Report

Devices descending from K002374

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd.201254—
+5K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+5K120043CSM Internal-R Implant SystemCsm Implant20121—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+5K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+5K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+5K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+5K101890Ball Abutment SystemMegagen Co., Ltd.20110—
+5K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2010111—
+5K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+5K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc.201038—
+5K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+5K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+5K082843Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd.20091—
+5K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+5K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+5K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+5K080744HG II Fixture SystemOsstem Implant Co., Ltd.2008112—
+5K072896GS Fixture SystemOsstem Implant Co., Ltd.200715—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+6K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K222707IH Implant SystemSewonmedix, Inc.20231—
+6K222792SNUCONE Tissue Level Implant SystemSnucone Co., Ltd.20232—
+6K221752StellaShinhung Mst Co., Ltd.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K212664SherlockOpen Implants, LLC20212—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+6K201981Magicore SystemInnobiosurg Co., Ltd.20204—
+6K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K192197Magicore II SystemInnobiosurg Co., Ltd.20203—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K192263UCLA CCM AbutmentDio Corporation20204—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171795Thommen Implant SystemThommen Medical AG20170—
+6K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+6K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+6K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+6K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+6K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—