510(k) Report

Devices descending from K033430

213 later devices reach 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K180609Rodo SmilekeyRodo Medical, Inc.20180—
+4K170394Kisses MiniAchimhai Medical Corporation20170—
+4K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+4K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231559Multi-Unit DAS SystemTalladium España, SL20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K232151Dynamic TiBaseTalladium España, SL20232—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K213391High Retention Attachment SystemZest Anchors, LLC20227—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K212664SherlockOpen Implants, LLC20212—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+5K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K243530Dynamic TiBaseTalladium España, SL20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.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—
+6K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220482SherlockOpen Implants, LLC20221—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+6K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250967SherlockOpen Implants, LLC20250—