BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    LEONE SPA

    Reg #: 3001561923 · FEI: 3001561923 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    33
    Establishment Types
    3
    Classifications
    25

    Registration Details

    Registration Name
    LEONE SPA
    Registration Number
    3001561923
    FEI Number
    3001561923
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50, VIA P. A QUARACCHI
    City
    Sesto Fiorentino Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K091702

    Owner / Operator

    Firm Name
    LEONE SPA
    Operator Number
    9051868
    Address
    50, Via P. a Quaracchi
    City
    Sesto Fiorentino
    State
    Firenze
    Postal Code
    I-50019
    Country
    IT
    Correspondent
    Elena - Pozzi

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Pusher, Band, Orthodontic ECS
    Clamp, Wire, Orthodontic ECN
    Band, Preformed, Orthodontic ECM
    Wire, Orthodontic DZC
    Headgear, Extraoral, Orthodontic DZB
    Bracket, Ceramic, Orthodontic NJM
    Instrument, Cutting, Operative EKD
    Alloy, Other Noble Metal EJS
    Bracket, Metal, Orthodontic EJF
    Instrument, Ligature Tucking, Orthodontic ECP
    Pliers, Operative EJY
    Tray, Impression, Preformed EHY
    Plier, Orthodontic JEX
    Tube, Orthodontic DZD
    Retainer, Screw Expansion, Orthodontic DYJ
    Accessories, Retractor, Dental EIF
    Bur, Dental EJL
    Implant, Endosseous, Orthodontic OAT
    Spring, Orthodontic ECO
    Implant, Endosseous, Root-Form DZE
    Wax, Dental, Intraoral EGD
    Accessories, Implant, Dental, Endosseous NDP
    Clasp, Preformed EHP
    Aligner, Bracket, Orthodontic ECQ
    Band, Elastic, Orthodontic ECI

    Proprietary Names

    Band driver and adapter MEMORIA CALIBRA WEB LEOLOY BIOSTELL LEOWIRE Orthodontic headgear, facemask/bow AQUA/Ceramic brackets Surgical instruments Noble alloys MIDI DIAGONALI MINI DIAGONALI METAL BRACKETS Orthodontic ligature instruments Pliers, operative Impression Tray Orthodontic pliers and instruments METAL TUBES MIM Thermoplastic material Mandibular advancers LEONE EXPANDERS Lip retractor BURS DRILLS Leone Orthodontic Mini Implant LEONE IMPLANT SYSTEM Dental wax Surgical and prosthetic accessories PREFORMED CLASP Bracket positioning gauges Elastics and ligatures

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device