510(k) Report

Devices descending from K013067

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+7K232383iPhysio® SystemEuroteknika20250—
+7K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K230103Klockner AbutmentsSoadco, S.L.20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K213677Bonafix 2 PlusZentek Medical, LLC20220—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+7K212664SherlockOpen Implants, LLC20212—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+7K200386Z5-BLZ-Systems AG20200—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K191123Multi-unit AbutmentsMedentika GmbH202011—
+7K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+7K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+7K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+7K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+7K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+7K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+8K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+8K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—