510(k) Report

Devices descending from K915375

325 later devices reach Odontit Osseointegrated Implants System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+7K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+7K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K152555Dental Implant SystemAriabio International, Inc.20160—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+7K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+7K151599iSy Implant SystemAltatec GmbH20150—
+7K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+7K133362SGS Dental ImplantSgs International, Ltd.20142—
+7K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+7K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+7K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+7K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+8K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+8K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+8K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+8K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+8K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+8K222636ET Abutment SystemHiossen, Inc.20230—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+8K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+8K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+8K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+8K220022TRATE Dental Implant SystemTrate AG20221—
+8K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+8K213391High Retention Attachment SystemZest Anchors, LLC20227—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+8K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+8K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+8K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+8K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+8K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+8K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+8K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+8K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+9K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+9K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+9K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+9K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+9K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+9K240143JDZygoma dental implantsJdentalcare Srl20240—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+9K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+9K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+9K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+9K222976MU SystemDentis Co., Ltd.20230—