510(k) Report

Devices descending from K102436

203 later devices reach Nobel Active 3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+1K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+1K142260NobelActiveNobel Biocare AB201599—
+1K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+1K141450AXIOM 2.8Anthogyr Sas201401
+1K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+1K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+1K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+1K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+1K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+1K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+1K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+1K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+1K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+2K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+2K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+2K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+2K212538DESS Dental ImplantsTerrats Medical SL20211—
+2K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+2K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+2K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+2K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+2K190552JJ Implant SystemJj Implants20190—
+2K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+2K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+2K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+2K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+2K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+2K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+2K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+2K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+2K152555Dental Implant SystemAriabio International, Inc.20160—
+2K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+2K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+2K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+2K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+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—
+2K133991ISYAltatec GmbH20142—
+2K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+2K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+2K123386Periotype X-PertClinical House Europe GmbH20131—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K251280DESS® Dental ImplantsTerrats Medical SL20250—
+3K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+3K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+3K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+3K220022TRATE Dental Implant SystemTrate AG20221—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+3K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+3K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+3K191152MIS Ti-base AbutmentDentsply Sirona20201—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+3K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+3K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+3K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—