BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GUM® Proxabrush Interdental Brush 1.1mm

    Reg #: 1413787 · FEI: 1413787 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SUNSTAR AMERICAS, INC.
    Registration Number
    1413787
    FEI Number
    1413787
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    301 East Central Road
    City
    Schaumburg
    State
    IL
    ZIP
    60195
    Country
    US

    Regulatory Submissions

    510(k) Number
    K974761

    Owner / Operator

    Firm Name
    Sunstar Americas, Inc.
    Operator Number
    9016423
    Address
    301 E Central Rd
    City
    Schaumburg
    State
    IL
    Postal Code
    60195
    Country
    US
    Correspondent
    Paula Wendland

    Products

    Device Name Product Code
    Toothbrush, Manual EFW

    Proprietary Names

    GUM® Proxabrush Interdental Brush 1.1mm GUM® Proxabrush Interdental Brush 1.4mm TRAV-LER GUM® Proxabrush Interdental Brush 1.6mm GUM® Proxabrush Interdental Brush 1.3mm GUM® Proxabrush Interdental Brush 1.2mm GUM® Proxabrush Interdental Brush 0.6mm GUM® Proxabrush Interdental Brush 0.8mm

    Establishment Types

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