510(k) Report

Devices descending from K013067

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K220482SherlockOpen Implants, LLC20221—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+8K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+8K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+8K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+8K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+9K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+10K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+10K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+11K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+12K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—