BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Premier

    DI: D6919007544 · Model: 9007544 · PREMIER DENTAL PRODUCTS COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Premier
    Primary DI
    D6919007544
    Version / Model
    9007544
    Company Name
    PREMIER DENTAL PRODUCTS COMPANY
    Labeler DUNS
    014789663
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    4
    Public Version Date
    2025-07-17
    Public Version Status
    Update
    Public Device Record Key
    b52271af-380a-4ae2-b006-30e8e2c51a29
    Distribution End Date
    2025-07-16

    Device Description

    EP Varnish Clear-Bubblegum .40 ml (200)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LBH Varnish, Cavity

    GMDN Terms

    Code Name
    35698 Dental cavity varnish

    Identifiers

    Type ID
    Primary D6919007544

    Premarket Submissions

    Submission Number Supplement Number
    K062683 000