510(k) Report

Devices descending from K022113

463 later devices reach 3I Dental Implant Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K212664SherlockOpen Implants, LLC20212—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K220482SherlockOpen Implants, LLC20221—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+10K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+11K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+12K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—