510(k) Report

Devices descending from K043195

167 later devices reach Neo Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211396Neoss Individual ProstheticsNeoss, Ltd.20220—
+1K150669Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)Neoss, Ltd.201514—
+1K120954Nobelprocera Peek AbutmentsNobel Biocare AB2013105—
+1K090452Neoss Implant System 03.25Neoss, Ltd.20093—
+1K083561Neoss Proactive ImplantNeoss, Ltd.20095—
+1K071838Neoss Various Titanium AbutmentsNeoss, Ltd.200774—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K172160Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd.20182—
+2K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+2K161435Temporary Snap AbutmentNobel Biocare AB201601
+2K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+2K113376Neoss Proactive Tapered ImplantNeoss, Ltd.20120—
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+2K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+3K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K191250Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd.20191—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K142260NobelActiveNobel Biocare AB201599—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+4K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+4K190552JJ Implant SystemJj Implants20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—