BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    AQUA/Ceramic brackets

    Reg #: 3001561923 · FEI: 3001561923 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LEONE SPA
    Registration Number
    3001561923
    FEI Number
    3001561923
    Status
    Active
    Expiry Year
    2025
    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
    Bracket, Ceramic, Orthodontic NJM

    Proprietary Names

    AQUA/Ceramic brackets

    Establishment Types

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