510(k) Report

Devices descending from K974358

392 later devices reach Frialit -2 Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+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—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+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—
+6K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+6K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+6K113606NNC Gold Abutment for BridgesStraumann USA20120—
+6K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K212664SherlockOpen Implants, LLC20212—
+7K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—