510(k) Report

Devices descending from K961737

550 later devices reach Cera One Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K133991ISYAltatec GmbH20142—
+6K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+6K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+6K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+6K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+6K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+6K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+6K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+6K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+6K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+6K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+6K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+6K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+6K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+6K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+6K103280Bhdental Implant SystemBhdental, Ltd.20110—
+6K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+6K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+6K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+6K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+6K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+6K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+6K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+6K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K232383iPhysio® SystemEuroteknika20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K230103Klockner AbutmentsSoadco, S.L.20230—
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+7K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+7K213599SuperLineDentium Co., Ltd.20220—
+7K212538DESS Dental ImplantsTerrats Medical SL20211—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K193352AbutmentCADExocad GmbH20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+7K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+7K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+7K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+7K200100Abutment Design3Shape A/S20203—
+7K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+7K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+7K191152MIS Ti-base AbutmentDentsply Sirona20201—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K190552JJ Implant SystemJj Implants20190—
+7K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+7K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+7K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K183518Preat AbutmentsPreat Corporation2019223
+7K181932DTX Studio designNobel Biocare AB20190—
+7K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+7K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+7K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+7K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+7K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+7K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+7K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+7K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+7K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+7K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+7K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—