510(k) Report

Devices descending from K061809

212 later devices reach Artegral Imcrown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140894Argen PmmaThe Argen Corporation20140—
+1K071548Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH2007211—
+2K150432Idodentine Disc, Idodentine BlockUnion Dental S.A.201523—
+2K140758M-PM-Disc (Pink)Merz Dental GmbH201417—
+2K134015M-PM-DiscMerz Dental GmbH20141—
+2K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+3K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+3K201683PMMA BlockHuge Dental Material Co., Ltd.20202—
+3K200676ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPAZirkonzahn Srl20200—
+3K191836Ceramill A-SplintAmann Girrbach AG20190—
+3K190107VeriSplintWhip Mix Corporation201910—
+3K180578Harvest Dental Polymer BlocksHarvest Dental Products, LLC20183—
+3K180562Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon…Zirkonzahn GmbH20181—
+3K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry20161—
+3K153490DD medical polymersDental Direkt GmbH20161—
+3K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+3K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K151142Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidWieland Dental + Technik GmbH & Co. KG201514—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230445OnX ToughSprintray, Inc.20232—
+4K230410DD medical polymers (PMMA)Dental Direkt GmbH20230—
+4K223706Pmma BlockHuliang (Shanghai) Bio-Tech Co., Ltd.20231—
+4K230115Denture Base ResinAidite (Qinhuangdao) Technology Co., Ltd.20230—
+4K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K210977E-Dent 1000Envisiontec GmbH20217—
+4K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries)202161
+4K201173E-GuardEnvisiontec GmbH202021
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K191926VITA VIONIC BondVita Zanhnfabrik H. Rauter GmbH Co.20201—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192153Portux CAD/CAM DiscNew Stetic, SA20192—
+4K183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2DMG Chemisch-Pharmazeutische Fabrik GmbH20190—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K172683Yamahachi Pink CAD/CAM DiskYAMAHACHI DENTAL MFG., Co.20180—
+4K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K160784CAM Titanium BlanksAltatec GmbH20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K262681NanoCeram Resin3BFAB Teknoloji a.S.20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.20260—
+5K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+5K241673Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd.20240—
+5K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+5K231775GR Resin System MSIPro3Dure Medical20240—
+5K240688RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak20241—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K232448FREEPRINT® splintmasterDetax GmbH20230—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K232691PolibondZirkonzahn Srl20230—
+5K223663SIMDA AbutmentSimda Co., Ltd.20232—
+5K222489Harvest Printable ResinHarvest Dental Products, LLC20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K222623Digital CrownSprintray, Inc.20224—
+5K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+5K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc.20221—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K220771Stratasys TrueDentStratasys, Ltd.202215
+5K212017Thermeo SystemPro3Dure Medical GmbH20221—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K211415GR Splint Resin SystemPro3Dure Medical GmbH20212—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—