510(k) Report

Devices descending from K992937

735 later devices reach Dental Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K212538DESS Dental ImplantsTerrats Medical SL20211—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+7K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+7K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+7K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+7K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+7K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+7K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+7K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+7K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+8K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+8K251280DESS® Dental ImplantsTerrats Medical SL20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K230103Klockner AbutmentsSoadco, S.L.20230—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K191123Multi-unit AbutmentsMedentika GmbH202011—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+8K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K171532TruBase STruabutment, Inc.20187—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+8K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+8K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—