BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prime Dent Flowable Composite Shade A2

    DI: 00817441020739 · Model: 004-101A2 · PRIME DENTAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prime Dent Flowable Composite Shade A2
    Primary DI
    00817441020739
    Version / Model
    004-101A2
    Company Name
    PRIME DENTAL
    Labeler DUNS
    027480775
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-04
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f1727a28-32a7-41f3-8fdb-00da1a6c2d9a

    Device Description

    Prime Dent Flowable Composite Shade A2- 4.5g Syringe

    Device Characteristics

    Single Use
    No
    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
    EBF Material, Tooth Shade, Resin

    GMDN Terms

    Code Name
    35870 Dental composite resin

    Identifiers

    Type ID
    Primary 00817441020739