BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SureSmile VPro Mouthpiece

    Reg #: 2950160 · FEI: 1000123971 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WRIGHT ENGINEERED PLASTICS, INC.
    Registration Number
    2950160
    FEI Number
    1000123971
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3681 N Laughlin Rd
    City
    Santa Rosa
    State
    CA
    ZIP
    95403
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183018

    Owner / Operator

    Firm Name
    WRIGHT ENGINEERED PLASTICS, INC.
    Operator Number
    9002508
    Address
    3681 North Laughlin Road, --
    City
    Santa Rosa
    State
    CA
    Postal Code
    95403
    Country
    US
    Correspondent
    Tom Orr

    Products

    Device Name Product Code
    Orthodontic Vibratory Accessory OYH

    Proprietary Names

    SureSmile VPro Mouthpiece HyperByte Mouthpiece

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)