BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REGEN Pit & Fissure Sealant

    Reg #: 2133714 · FEI: 3000209941 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INTER-MED, INC.
    Registration Number
    2133714
    FEI Number
    3000209941
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2200 South St
    City
    Racine
    State
    WI
    ZIP
    53404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190998

    Owner / Operator

    Firm Name
    INTER-MED, INC.
    Operator Number
    9025886
    Address
    2200 South Street, --
    City
    Racine
    State
    WI
    Postal Code
    53404
    Country
    US

    Products

    Device Name Product Code
    Sealant, Pit And Fissure, And Conditioner EBC

    Proprietary Names

    REGEN Pit & Fissure Sealant

    Establishment Types

    Manufacture Medical Device