BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LUNE™ PureHygiene

    Reg #: 3032916575 · FEI: 3032916575 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Enamel Pure Inc.
    Registration Number
    3032916575
    FEI Number
    3032916575
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17 Briden St
    City
    Worcester
    State
    MA
    ZIP
    01605
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234085

    Owner / Operator

    Firm Name
    Enamel Pure
    Operator Number
    10091424
    Address
    17 Briden Street
    City
    Worcester
    State
    MA
    Postal Code
    01605
    Country
    US
    Correspondent
    Dhaval Saraiya

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    LUNE™ PureHygiene

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility