510(k) Report

Devices descending from K063364

187 later devices reach Alpha Bio Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+1K162299Spiral Shape Dental Implant SystemGp Implants20173—
+1K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+1K133362SGS Dental ImplantSgs International, Ltd.20142—
+1K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+1K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+1K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+1K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+1K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+1K103280Bhdental Implant SystemBhdental, Ltd.20110—
+1K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+1K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+1K071803Ards Dental ImplantsArds, Ltd.200813—
+2K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+2K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+2K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+2K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+2K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+2K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+2K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+2K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+2K172240SPI Dental Implant SystemMsi France20180—
+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—
+2K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+2K152555Dental Implant SystemAriabio International, Inc.20160—
+2K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+2K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+2K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+2K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+2K131701Z5MLB, Z5MLCZ-Systems AG20131—
+2K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+2K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+2K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+2K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+3K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+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—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K213677Bonafix 2 PlusZentek Medical, LLC20220—
+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—
+3K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+3K200386Z5-BLZ-Systems AG20200—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+3K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+3K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+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—
+3K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+3K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+3K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+4K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+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—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—