BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OpalDam

    Reg #: 1718912 · FEI: 1718912 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ultradent Products Inc. / OraTech LLC
    Registration Number
    1718912
    FEI Number
    1718912
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    505 W Ultradent Dr (10200 South)
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US

    Regulatory Submissions

    510(k) Number
    K971284

    Owner / Operator

    Firm Name
    ULTRADENT PRODUCTS, INC.
    Operator Number
    1718962
    Address
    505 West Ultradent Drive (10200 South), --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    Products

    Device Name Product Code
    Retractor, All Types EIG

    Proprietary Names

    OpalDam OpalDam Green OT Gingival Barrier

    Establishment Types

    Manufacture Medical Device