510(k) Report

Devices descending from K030614

319 later devices reach 3I Dental Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728—
+1K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312—
+1K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004318—
+2K122300T3 Dental ImplantBiomet 3i2013223
+2K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+2K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+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—
+2K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc.200720910
+2K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20072115
+2K062432Nanotite Dental ImplantsImplant Innovations, Inc.200759—
+2K051189Prevail Dental ImplantsImplant Innovations, Inc.2005317—
+3K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K160119NobelSpeedy GroovyNobel Biocare AB20167—
+3K142426EBI External Implant SystemEbi, Inc.20150—
+3K142167Medentika Abutment SystemMedentika GmbH20157—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+3K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K113779Conelog Implant SystemAltatec GmbH201214—
+3K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+3K120414Osseospeed PlusAstra Tech AB2012196—
+3K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+3K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+3K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+3K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+3K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+3K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+3K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+3K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+4K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+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—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K211872PiezoImplant SystemRex Implants, Inc.20220—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+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—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+4K200102MIS Dental Implant SystemDentsply Sirona20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173701Implant-One SystemImplant Logistics, Inc.20181—
+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