510(k) Report

Devices descending from K003226

400 later devices reach The Lifecore Stage-1 Single Stage RBM Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+1K072768Restore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc.200702
+1K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc.20060—
+1K051576Avana Dental Implant SystemOsstem Co., Ltd.2005222—
+1K021322Endossous ImplantsIntra-Lock International20026—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+2K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+2K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+2K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+2K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+2K073116Ebi Internal Implant SystemEbi, Inc.20083—
+2K062030US SystemOsstem Implant Co., Ltd.2006183—
+2K062051SS SystemOsstem Implant Co., Ltd.2006211—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+3K172100URIS OMNI SystemTruabutment, Inc.20187—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K171179BR Type Implant SystemBiotem Co., Ltd.20181—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K171185IR Type Implant SystemBiotem Co., Ltd.20171—
+3K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+3K170031Internal Octa Implant SystemEbi, Inc.20171—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+3K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+3K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+3K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+3K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+3K142426EBI External Implant SystemEbi, Inc.20150—
+3K140051KJ External Implant SystemKj Meditech Co., Ltd.20140—
+3K140052J2I Implant SystemKj Meditech Co., Ltd.20140—
+3K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+3K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+3K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+3K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+3K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+3K090527Sinus Quick IT SystemNeobiotech Co., Ltd.20097—
+3K081579Inventus Implant SystemInventus Co., Ltd.20080—
+3K081575HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2008129—
+3K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+3K073465US/GS Ultra Wide SystemOsstem Implant Co., Ltd.200890—
+3K080387HU II / HS II Fixture SystemOsstem Implant Co., Ltd.200877—
+3K073247US/SS/GS SystemOsstem Implant Co., Ltd.2008141—
+3K063861GS SystemOsstem Implant Co., Ltd.2007202—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K232383iPhysio® SystemEuroteknika20250—