510(k) Report

Devices descending from K031106

227 later devices reach Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K213677Bonafix 2 PlusZentek Medical, LLC20220—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K120198Locator Overdenture Implant SystemZest Anchors, LLC201221
+4K093518Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc.201021
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+5K203701Locator Overdenture Implant SystemIvory Super Holdco Inc. / Zest Anchors, LLC20210—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193335SherlockOpen Implants, LLC20203—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—