510(k) Report

Devices descending from K013798

575 later devices reach Prosthetic Accessories to the Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+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
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K172798Straumann CARES Abutments CoCrInstitut Straumann AG20180—
+5K162848Straumann CARES Golden Ti/TiN AbutmentsInstitut Straumann AG20170—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151439Atlantis IsusDentsply International, Inc.20160—
+5K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+5K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+5K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+5K133991ISYAltatec GmbH20142—
+5K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+5K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+5K132214Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Hager& Meisinger GmbH20149—
+5K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+5K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+5K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+5K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+5K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+5K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+5K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+5K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+5K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+5K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+5K110580Narrow Connection Straumann Anatomic Ips E.Max AbutmentsStraumann USA20110—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+5K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+5K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+5K093027Straumann RC Temporary AbutmentsStraumann USA201097—
+5K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+5K091848Nobel/Procera Implant BridgeNobel Biocare AB20091—
+5K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+5K091904Nobelprocera ZI AbutmentNobel Biocare AB200935—
+5K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+5K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20082631
+5K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008179—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—