510(k) Report

Devices descending from K962014

493 later devices reach 3I Single Use, Disposable Drills,Taps,Burs, Etc. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+7K151599iSy Implant SystemAltatec GmbH20150—
+7K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+7K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+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—
+8K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+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—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+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—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K241616ALLONUS Tech ProstheticsAllonus Tech Co., 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—
+8K240511Dentis s-Clean SQ-SL FixtureDentis Co., 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—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+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—
+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—
+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—