510(k) Report

Devices descending from K952811

464 later devices reach 3I Oral/Maxillofacial Bone Fixation System: Stainless Steel Bone-Mesh/Plate &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+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—
+8K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+8K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+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—
+8K220517IBS SystemInnobiosurg Co., Ltd.20220—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+8K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+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—
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+8K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+8K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+8K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+8K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+8K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+9K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+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—
+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—
+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—
+9K220482SherlockOpen Implants, LLC20221—
+9K220252High Retention Attachment SystemZest Anchors, LLC20221—
+10K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+10K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250967SherlockOpen Implants, LLC20250—
+10K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+10K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+10K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+11K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+12K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+13K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—