BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JET SET-4 TOOTH SHADE POWDER

    DI: D6503830OM10 · Model: 454 GRAM SHADE OM1 · LANG DENTAL MANUFACTURING CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JET SET-4 TOOTH SHADE POWDER
    Primary DI
    D6503830OM10
    Version / Model
    454 GRAM SHADE OM1
    Catalog Number
    3830OM1
    Company Name
    LANG DENTAL MANUFACTURING CO., INC.
    Labeler DUNS
    005185798
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    4
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    21ecde41-6be2-4fb4-b8ec-edf1517cdc18

    Device Description

    VERY FAST CURING PROVISIONAL CROWN & BRIDE ACRYLIC RESIN POWDER

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    45236 Temporary dental crown/bridge resin

    Identifiers

    Type ID
    Primary D6503830OM10

    Premarket Submissions

    Submission Number Supplement Number
    K083195 000