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
+1K191895Straumann Mini ImplantsInstitut Straumann AG20193—
+1K162867MagDen Dental Implant SystemShinhung Mst Co., Ltd.20171—
+1K153173MOR Implant SystemSterngold Dental, LLC20160—
+1K141450AXIOM 2.8Anthogyr Sas201401
+1K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+1K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+1K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+1K131701Z5MLB, Z5MLCZ-Systems AG20131—
+1K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+1K112758Kat Implants System One-Piece Implants 2.5X10Kat Implants, LLC20120—
+1K111162Slim Onebody SystemDentium Co., Ltd.20120—
+1K100932Inclusive Mini ImplantPrismatik Dentalcraft, Inc.201015—
+1K100902Aedis (TM)Embed Technology, LLC20100—
+1K092674Simpler Toadstool Mini ImplantPan Global Implant20090—
+1K090049Atlas Implant System- Mini PlusCowellmedi Co., Ltd.20090—
+1K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+1K083886Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004Simpler One Stop20092—
+1K083544Kat Implant SystemKat Implants, LLC20094—
+1K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+1K080115I-Mini Dental ImplantOco Biomedical20081—
+1K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International2007144—
+1K070483Leone Monoimplant for O-Ring OverdentureLeone S.P.A.20070—
+1K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+2K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+2K211052Straumann RidgeFit ImplantsInstitut Straumann AG20211—
+2K200906MINICONE ImplantMedentika GmbH20200—
+2K200386Z5-BLZ-Systems AG20200—
+2K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+2K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+2K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+2K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+2K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+2K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+2K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+2K162299Spiral Shape Dental Implant SystemGp Implants20173—
+2K152555Dental Implant SystemAriabio International, Inc.20160—
+2K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+2K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+2K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+2K121406Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc.201311—
+2K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+2K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+2K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+2K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+2K101201Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model…Kat Implants, LLC20113—
+2K103280Bhdental Implant SystemBhdental, Ltd.20110—
+2K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+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—
+2K071803Ards Dental ImplantsArds, Ltd.200813—
+2K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008135—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K250294Straumann® RidgeFit ImplantsInstitut Straumann AG20250—
+3K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+3K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+3K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+3K220022TRATE Dental Implant SystemTrate AG20221—
+3K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+3K172240SPI Dental Implant SystemMsi France20180—
+3K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+3K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+3K153099Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc.20163—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+3K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+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—
+3K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+3K143353Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc.201510—
+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—
+3K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+3K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+3K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc.2009134—
+4K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—