510(k) Report

Devices descending from K042658

441 later devices reach Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+3K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+3K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+3K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+3K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+3K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+3K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+3K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+4K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+4K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+4K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+4K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+4K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+4K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+4K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K193352AbutmentCADExocad GmbH20210—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+4K200100Abutment Design3Shape A/S20203—
+4K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+4K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+4K191152MIS Ti-base AbutmentDentsply Sirona20201—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K190552JJ Implant SystemJj Implants20190—
+4K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+4K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K181932DTX Studio designNobel Biocare AB20190—
+4K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+4K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+4K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+4K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+4K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+4K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+4K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—