BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CORE Delivery Unit

    Reg #: 1049061 · FEI: 1049061 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DENTALEZ OF ALABAMA
    Registration Number
    1049061
    FEI Number
    1049061
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2500 U.S. HIGHWAY 31 SOUTH
    City
    BAY MINETTE
    State
    AL
    ZIP
    36507
    Country
    US

    Regulatory Submissions

    510(k) Number
    K931204

    Owner / Operator

    Firm Name
    DENTALEZ, INC.
    Operator Number
    2513147
    Address
    301 Lindenwood Drive, Suite 100
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    Unit, Operative Dental EIA

    Proprietary Names

    CORE Delivery Unit Galaxy Delivery Unit

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198