510(k) Report

Devices descending from K033243

514 later devices reach Iti Synocta Meso Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+3K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+3K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+3K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+3K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K172798Straumann CARES Abutments CoCrInstitut Straumann AG20180—
+3K162848Straumann CARES Golden Ti/TiN AbutmentsInstitut Straumann AG20170—
+3K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+3K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+3K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+3K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+3K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+3K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+3K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+3K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+3K160784CAM Titanium BlanksAltatec GmbH20161—
+3K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+3K151439Atlantis IsusDentsply International, Inc.20160—
+3K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+3K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+3K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+3K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+3K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+3K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+3K133991ISYAltatec GmbH20142—
+3K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+3K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+3K132214Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Hager& Meisinger GmbH20149—
+3K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+3K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+3K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+3K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+3K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+3K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+3K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+3K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+3K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+3K110580Narrow Connection Straumann Anatomic Ips E.Max AbutmentsStraumann USA20110—
+3K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+3K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+3K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+3K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+3K093027Straumann RC Temporary AbutmentsStraumann USA201097—
+3K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+3K091848Nobel/Procera Implant BridgeNobel Biocare AB20091—
+3K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+3K091904Nobelprocera ZI AbutmentNobel Biocare AB200935—
+3K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+3K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20082631
+3K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008179—
+4K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+4K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+4K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+4K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+4K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+4K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+4K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+4K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K223663SIMDA AbutmentSimda Co., Ltd.20232—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—