510(k) Report

Devices descending from K031475

330 later devices reach Osseotite NT Certain Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+4K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+4K220823Preat AbutmentsPreat Corporation202216
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K211872PiezoImplant SystemRex Implants, Inc.20220—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+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—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160244VARIOuniteThommen Medical AG201615—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K1505713i T3 Short ImplantsBiomet 3i20151—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K150295LOCATOR RTxZest Anchors, Inc.201542—
+4K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+4K063106Revois Implant SystemCurasan AG20072—
+5K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—