BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ultra SEP

    DI: D798USEP0 · Model: USEP · RELIANCE ORTHODONTIC PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ultra SEP
    Primary DI
    D798USEP0
    Version / Model
    USEP
    Company Name
    RELIANCE ORTHODONTIC PRODUCTS INC
    Labeler DUNS
    113170088
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-03
    Public Version
    2
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    4a7a0192-990f-480a-bb41-ab937074d910

    Device Description

    6 ml bottle Ultra SEP

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KLE Agent, Tooth Bonding, Resin

    GMDN Terms

    Code Name
    36153 Dental tooth-etching solution

    Identifiers

    Type ID
    Primary D798USEP0

    Premarket Submissions

    Submission Number Supplement Number
    K210945 000