BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EPIEN MEDICAL, INC.

    Reg #: 3003428492 · FEI: 3003428492 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    EPIEN MEDICAL, INC.
    Registration Number
    3003428492
    FEI Number
    3003428492
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4225 White Bear Parkway, SUITE 600
    City
    White Bear Lake
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201785

    Owner / Operator

    Firm Name
    EPIEN MEDICAL, INC.
    Operator Number
    9088699
    Address
    4225 White Bear Parkway, SUITE 600
    City
    White Bear Lake
    State
    MN
    Postal Code
    55110
    Country
    US

    Products

    Device Name Product Code
    Cleanser, Root Canal KJJ
    Bandage, Liquid, Skin Protectant NEC

    Proprietary Names

    HRCC HybenX Root Canal Cleanser ERCC EPIEN Root Canal Cleanser HYBENX ORAL MEDIC APTHE RELIEF (FOR EXPORT ONLY)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)