BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FluoriMax

    Reg #: 3009603151 · FEI: 3009603151 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ELEVATE ORAL CARE, LLC
    Registration Number
    3009603151
    FEI Number
    3009603151
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    346 Pike Rd Ste 1, 5, 7, 13, & 23
    City
    West Palm Beach
    State
    FL
    ZIP
    33411
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131376

    Owner / Operator

    Firm Name
    Elevate Oral Care
    Operator Number
    10041046
    Address
    346 Pike Road, Suite 1, 5, 13, & 23
    City
    West Palm Beach
    State
    FL
    Postal Code
    33411
    Country
    US
    Correspondent
    Teri Sturgell

    Products

    Device Name Product Code
    Varnish, Cavity LBH

    Proprietary Names

    FluoriMax

    Establishment Types

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