510(k) Report

Devices descending from K031475

330 later devices reach Osseotite NT Certain Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K212664SherlockOpen Implants, LLC20212—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+5K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220482SherlockOpen Implants, LLC20221—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+6K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—