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
+4K043428Reliadent Dental Implant SystemBioinfera, Inc.20052—
+4K051502Spi Dental ImplantThommen Medical AG20052—
+4K050208Friadent EstheticapDentsply International20053—
+4K051189Prevail Dental ImplantsImplant Innovations, Inc.2005317—
+4K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.200543—
+4K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004622—
+4K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004328—
+4K024004Xive Transgingival Dental Implant SystemFriadent GmbH2003425—
+4K021318Xive Dental Implant SystemFriadent GmbH2002547—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251280DESS® Dental ImplantsTerrats Medical SL20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+5K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K193352AbutmentCADExocad GmbH20210—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+5K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200100Abutment Design3Shape A/S20203—
+5K200102MIS Dental Implant SystemDentsply Sirona20200—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+5K190552JJ Implant SystemJj Implants20190—
+5K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+5K191201EM SA Implant SystemHiossen, Inc.20191—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—