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
+5K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc.20114—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+5K090234Spectra System Dental Implants 2008Implant Direct, LLC20092211
+5K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+5K082749Omni-TightBasic Dental Implant Systems, Inc.20080—
+5K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+5K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+5K073116Ebi Internal Implant SystemEbi, Inc.20083—
+5K073073Ankylos Temporary Abutment BalanceDentsply International, Inc.20080—
+5K071148Atlas Implant SystemCowellmedi Co., Ltd.20084—
+5K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070—
+5K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+5K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+5K062030US SystemOsstem Implant Co., Ltd.2006183—
+5K062051SS SystemOsstem Implant Co., Ltd.2006211—
+5K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+5K053099Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc.20061—
+5K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc.20060—
+5K050406Nobelspeedy ImplantsNobel Biocare AB2005234—
+5K050705Tiunite ImplantsNobel Biocare AB20055321
+5K050258Groovy ImplantsNobel Biocare AB200551128
+5K041509Ankylos Dental Implant SystemFriadent GmbH2004325—
+5K032302Xive TG AbutmentsFriadent GmbH200395—
+5K032158Xive Dental Implant System MultipleFriadent GmbH2003542—
+5K032284Xive TG Dental Implant SystemFriadent GmbH2003394—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC20250—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+6K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+6K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K232383iPhysio® SystemEuroteknika20250—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+6K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+6K242379LL Implant SystemOssvis Co., Ltd.20240—
+6K242261Accelx Implant SystemBiotech Dental, LLC20240—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+6K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+6K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+6K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K221107TRUSTRgorithm Korea20230—
+6K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+6K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K221752StellaShinhung Mst Co., Ltd.20230—
+6K222738Point implant systemPointnix Co., Ltd.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—