510(k) Report

Devices descending from K820013

357 later devices reach Titanium Implant Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220823Preat AbutmentsPreat Corporation202216
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+7K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+7K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K193335SherlockOpen Implants, LLC20203—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+7K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+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—
+7K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K152555Dental Implant SystemAriabio International, Inc.20160—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+7K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+7K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+7K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+7K151599iSy Implant SystemAltatec GmbH20150—
+7K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+7K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+7K133362SGS Dental ImplantSgs International, Ltd.20142—
+7K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+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—
+8K243066Dental Implants and AbutmentsDitron Dental, 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—
+8K233231Dental Implants and AbutmentsDitron Dental, 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—