510(k) Report

Devices descending from K935544

601 later devices reach 3I Standard Threaded/Self-Tapping Threaded Implants Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728—
+1K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc.200720910
+1K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20072115
+1K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312—
+1K051189Prevail Dental ImplantsImplant Innovations, Inc.2005317—
+1K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd.200491—
+1K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc.2003320—
+1K0306143I Dental ImplantsImplant Innovations, Inc.2003319—
+1K031475Osseotite NT Certain ImplantsImplant Innovations, Inc.2003330—
+1K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002478—
+1K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002463—
+1K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002583—
+1K013570Osseotite Dental ImplantsImplant Innovations, Inc.2001495—
+2K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K160119NobelSpeedy GroovyNobel Biocare AB20167—
+2K142426EBI External Implant SystemEbi, Inc.20150—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+2K140934Hiossen Implant SystemHiossen, Inc.201413—
+2K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+2K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+2K122300T3 Dental ImplantBiomet 3i2013223
+2K113779Conelog Implant SystemAltatec GmbH201214—
+2K120414Osseospeed PlusAstra Tech AB2012196—
+2K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+2K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+2K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+2K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+2K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+2K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+2K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+2K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+2K073458BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl20082—
+2K072363Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc.200835—
+2K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+2K070935T.B.R. ZirconnectSudimplant SA20070—
+2K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+2K063734Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc.200738—
+2K062197Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ AbutmentAtlantis Components, Inc.20070—
+2K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+2K062432Nanotite Dental ImplantsImplant Innovations, Inc.200759—
+2K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc.2007361—
+2K052254Mytis Arrow XXXXBrainbase Corporation20060—
+2K050956TBR Idea Conic/ConicSudimplant SA20062—
+2K052369Exfeel Implant SystemMegagen Co., Ltd.200684—
+2K050635Allfim Implant SystemsCowellmedi Co., Ltd.20055—
+2K042971Titan Dental Implant SystemTitan Implants, Inc.20050—
+2K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004318—
+2K040807Mis Dental Implant SystemMis - Implant Technologies, Ltd.2004218—
+2K0334303I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611…Implant Innovations, Inc.2003213—
+2K022258B.T.I. Biotechnology Institute, S.L. Dental Implant SystemB.T.I. Biotechnology Institute, Sl.200312—
+2K031055Iti Dental Implant SystemStraumann USA20034—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+3K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+3K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K211872PiezoImplant SystemRex Implants, Inc.20220—
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K213599SuperLineDentium Co., Ltd.20220—
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+3K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+3K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+3K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+3K200102MIS Dental Implant SystemDentsply Sirona20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+3K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+3K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+3K183518Preat AbutmentsPreat Corporation2019223