510(k) Report

Devices descending from K002475

596 later devices reach Replace TPS Coated Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+8K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+8K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+8K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+8K210039CORE1 Implant SystemCybermed, Inc.20220—
+8K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+8K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+8K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+8K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+8K211225MIS Ti-base abutmentDentsply Sirona20210—
+8K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+8K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+8K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+8K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+8K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+8K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+8K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+8K200355Duranext AbutmentsElegant Dental Corp.20200—
+8K193404UF (II) Bar holder abutmentDio Corporation20200—
+8K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+8K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+8K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+8K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+8K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+8K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+8K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+8K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+8K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+8K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+8K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+8K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+8K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+8K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+8K162390ET Hybrid AbutmentHiossen, Inc.20172—
+8K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+8K160784CAM Titanium BlanksAltatec GmbH20161—
+8K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+8K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+8K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+8K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+8K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+8K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+9K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+9K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+9K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+9K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+9K243278Custom AbutmentsInstitut Straumann AG202501
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+9K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+9K233389EK Digital AbutmentsHiossen, Inc.20240—
+9K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+9K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+9K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+9K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+9K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+9K223663SIMDA AbutmentSimda Co., Ltd.20232—
+9K220517IBS SystemInnobiosurg Co., Ltd.20220—
+9K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+9K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+9K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+9K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+9K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+9K192742Straumann Variobase CInstitut Straumann AG20211—
+9K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+9K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+9K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+9K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+9K171532TruBase STruabutment, Inc.20187—
+9K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+9K170421ET Hybrid AbutmentHiossen, Inc.20180—
+9K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+9K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+9K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+10K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+10K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+10K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+10K232271SIMDA abutmentSimda Co., Ltd.20230—
+10K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+10K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+10K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+10K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+10K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+10K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+11K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+11K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+11K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+11K201842TruBase STruabutment, Inc.20210—
+12K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+12K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+12K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+13K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+13K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+13K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—