510(k) Report

Devices descending from K994376

665 later devices reach Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+6K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K212664SherlockOpen Implants, LLC20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+6K1514553Shape Abutment Designer Software3Shape A/S201610—
+6K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemPrismatik Dentalcraft, Inc.20150—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+6K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+6K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+6K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+6K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+6K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+6K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+6K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+6K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+6K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+6K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+6K120043CSM Internal-R Implant SystemCsm Implant20121—
+6K110337Universal Maxillary MolarOco Biomedical20121—
+6K113606NNC Gold Abutment for BridgesStraumann USA20120—
+6K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+6K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+6K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+6K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+7K242261Accelx Implant SystemBiotech Dental, LLC20240—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—