510(k) Report

Devices descending from K050705

532 later devices reach Tiunite Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+1K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+1K101545Genesis Implant SystemKeystone Dental2010153
+1K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+1K081128Molar ImplantNobel Biocare AB20080—
+1K070184Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentOspol AB20081—
+1K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Zimmer Dental, Inc.20061221
+1K061003SFB & CFB ImplantsNobel Biocare AB2006507—
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+2K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+2K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+2K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+2K151928PUR Dental Implant SystemSterngold Dental, LLC20150—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc.20140—
+2K133339Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M…Zimmer Dental, Inc.20143—
+2K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+2K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+2K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+2K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+2K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+2K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+2K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+2K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+2K110577Osseofuse Dental Implant SystemDynamic Innovations, Inc.20114—
+2K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+2K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+2K101068Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC20100—
+2K072570Nobelactive Multi Unit AbutmentNobel Biocare AB20071811
+2K072589Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Zimmer Dental, Inc.2007983
+2K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074144
+2K063718SFB and CFB Implants - 5.0 PlatformNobel Biocare AB20070—
+2K062936Nobelperfect Conical ConnectionNobel Biocare AB20061—
+2K062566Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC200610927
+2K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB2006327—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K230103Klockner AbutmentsSoadco, S.L.20230—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K220823Preat AbutmentsPreat Corporation202216
+3K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+3K220978TSX ImplantsBiomet 3i, LLC20221—
+3K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+3K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K173701Implant-One SystemImplant Logistics, Inc.20181—
+3K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+3K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+3K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—