510(k) Report

Devices descending from K063341

209 later devices reach 3I Osseotite Certain Dental Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+3K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K181037DIO CAD/CAM AbutmentDio Corporation20187—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+3K1505713i T3 Short ImplantsBiomet 3i20151—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K142426EBI External Implant SystemEbi, Inc.20150—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+4K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+4K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+4K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243009Mist ICImagine Milling Technologies, LLC20251—
+4K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+4K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+4K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+4K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+4K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+4K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K212664SherlockOpen Implants, LLC20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K212108Dynamic TiBaseTalladium España, SL20219—
+4K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+4K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+4K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K261122Mist ICImagine Milling Technologies, LLC20260—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+5K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+5K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+5K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K221673Bonafix TiBaseZentek Medical, LLC20231—
+5K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K220482SherlockOpen Implants, LLC20221—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+6K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+6K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—