510(k) Report

Devices descending from K913255

616 later devices reach Ceramic (TM) Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+4K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+4K102804Spi Titanium Base for Cad/CamThommen Medical AG201183—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K101608Biomet 3I Patient Specific Dental Abutments-Encode AbutmentsBiomet 3i, Inc.20110—
+4K101607Biomet 3I Patient Specific Dental Abutments - Encode AbutmentsBiomet 3i, Inc.20110—
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K102209Encode Patient Specific AbutmentBiomet 3i, Inc.201015
+4K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+4K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+4K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+4K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+4K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+4K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+4K080864Cam Structsure Precision Milled BarsBiomet 3i, Inc.200814—
+4K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+4K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+4K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+4K052648Modification to 3I Patient-Specific Dental Abutments and Overdenture BarsImplant Innovations, Inc.20051713
+4K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+5K242261Accelx Implant SystemBiotech Dental, LLC20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K193352AbutmentCADExocad GmbH20210—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K200100Abutment Design3Shape A/S20203—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K191123Multi-unit AbutmentsMedentika GmbH202011—
+5K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K190552JJ Implant SystemJj Implants20190—
+5K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K181932DTX Studio designNobel Biocare AB20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+5K180998BioHorizons CAD/CAM BarsBioHorizons Implant Systems, Inc.20189—
+5K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K173466Panthera Dental Milled BarsPanthera Dental, Inc.20182—