510(k) Report

Devices descending from K981516

1,066 later devices reach Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+6K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+6K150295LOCATOR RTxZest Anchors, Inc.201542—
+6K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K140051KJ External Implant SystemKj Meditech Co., Ltd.20140—
+6K140052J2I Implant SystemKj Meditech Co., Ltd.20140—
+6K141450AXIOM 2.8Anthogyr Sas201401
+6K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+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—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K131066Axiom RegAnthogyr Sas20142—
+6K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+6K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+6K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+6K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+6K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+6K123386Periotype X-PertClinical House Europe GmbH20131—
+6K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122—
+6K120776Abutment for Competitive Implant Nobel Active ConnectionBiomet 3i20120—
+6K120043CSM Internal-R Implant SystemCsm Implant20121—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+6K090716Bego Semados S-LineBego Implant Systems GmbH & Co. KG20091—
+6K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+6K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+6K090527Sinus Quick IT SystemNeobiotech Co., Ltd.20097—
+6K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc.2009290—
+6K081101Spectra-System Abutments 2008Implant Direct, LLC200911—
+6K081128Molar ImplantNobel Biocare AB20080—
+6K081579Inventus Implant SystemInventus Co., Ltd.20080—
+6K081575HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2008129—
+6K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+6K073465US/GS Ultra Wide SystemOsstem Implant Co., Ltd.200890—
+6K070184Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentOspol AB20081—
+6K080387HU II / HS II Fixture SystemOsstem Implant Co., Ltd.200877—
+6K073247US/SS/GS SystemOsstem Implant Co., Ltd.2008141—
+6K073067Ankylos Dental Implant System/ClaimsDentsply International, Inc.20080—
+6K063861GS SystemOsstem Implant Co., Ltd.2007202—
+6K062936Nobelperfect Conical ConnectionNobel Biocare AB20061—
+6K062566Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC200610927
+6K061477Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB200666—
+6K061003SFB & CFB ImplantsNobel Biocare AB2006507—
+6K040170Friadent Plus Dental Implant SystemsFriadent GmbH200484—
+7K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+7K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+7K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+7K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K241032BellaTek BarsBiomet 3i, LLC20241—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.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—
+7K232528Protective CapNeobiotech Co., Ltd.20240—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+7K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K231079LW Retraction CapOssvis Co., Ltd.20230—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—