510(k) Report

Devices descending from K013067

568 later devices reach Frialoc Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+6K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+6K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193335SherlockOpen Implants, LLC20203—
+6K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K180609Rodo SmilekeyRodo Medical, Inc.20180—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K172240SPI Dental Implant SystemMsi France20180—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+6K170394Kisses MiniAchimhai Medical Corporation20170—
+6K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+6K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K153779Abutment for BridgesAltatec GmbH20161—
+6K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+6K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+6K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+6K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+6K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+6K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+6K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+6K131701Z5MLB, Z5MLCZ-Systems AG20131—
+6K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+6K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+6K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+6K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+6K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+6K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+6K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+6K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+6K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+6K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+7K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+7K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+7K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+7K251280DESS® Dental ImplantsTerrats Medical SL20250—