BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3D Dental - Joy

    DI: 00817169020233 · Model: JE-50R · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3D Dental - Joy
    Primary DI
    00817169020233
    Version / Model
    JE-50R
    Company Name
    3D DENTAL DESIGNS AND DEVELOPMENT, LLC
    Labeler DUNS
    080194935
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b11ace1e-5f37-40d2-9da7-0cad028cf034

    Device Description

    JOY ETCH BULK SYRINGE 50ML REFILL

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    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 etching solution

    Identifiers

    Type ID
    Primary 00817169020233