510(k) Report

Devices descending from K040143

145 later devices reach Monorail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International2007144—
+2K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+2K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+2K083669OBIEuroteknika20090—
+2K073645Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM659543 BC, Ltd.20083—
+2K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008135—
+3K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+3K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+3K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc.2009134—
+3K083886Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004Simpler One Stop20092—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+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—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K120198Locator Overdenture Implant SystemZest Anchors, LLC201221
+4K093518Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc.201021
+4K092674Simpler Toadstool Mini ImplantPan Global Implant20090—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+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—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+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—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+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—
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K232383iPhysio® SystemEuroteknika20250—
+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—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200386Z5-BLZ-Systems AG20200—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+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—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—