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
+6K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+6K150295LOCATOR RTxZest Anchors, Inc.201542—
+6K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+6K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+6K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+6K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+6K133991ISYAltatec GmbH20142—
+6K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+6K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+6K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+6K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+6K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+6K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+6K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+6K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+6K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+6K063106Revois Implant SystemCurasan AG20072—
+7K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K253341Custom Abutments ASMedentika GmbH20250—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+7K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+7K240383Highness Implant SystemHighness Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+7K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K220823Preat AbutmentsPreat Corporation202216
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K193335SherlockOpen Implants, LLC20203—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+7K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+7K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+7K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—