BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premier Scalers

    DI: 00348783007350 · Model: 1004682 · PREMIER DENTAL PRODUCTS COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Premier Scalers
    Primary DI
    00348783007350
    Version / Model
    1004682
    Company Name
    PREMIER DENTAL PRODUCTS COMPANY
    Labeler DUNS
    014789663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-17
    Public Version
    1
    Public Version Date
    2026-03-25
    Public Version Status
    New
    Public Device Record Key
    da08069e-99d7-46ab-b9c8-0253df9a8c2f

    Device Description

    PremierAir NV2

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EMN Scaler, Periodontic

    GMDN Terms

    Code Name
    35320 Manual dental scaler, reusable

    Identifiers

    Type ID
    Primary 00348783007350