BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IPS e.max ZirCAD

    DI: DIVO694516EN1 · Model: 694516EN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    11

    Basic Information

    Brand Name
    IPS e.max ZirCAD
    Primary DI
    DIVO694516EN1
    Version / Model
    694516EN
    Catalog Number
    694516EN
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    11
    Record Status
    Published
    Publish Date
    2019-08-21
    Public Version
    2
    Public Version Date
    2022-02-10
    Public Version Status
    Update
    Public Device Record Key
    44d0208d-8a82-49cf-a085-e0c2750bf620

    Device Description

    IPS e.max ZirCAD for PlanMill blocks, IPS e.max CAD Crystall./Glaze Paste Fluo, SpeedCEM Plus, OptraGate

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIH POWDER, PORCELAIN

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Primary DIVO694516EN1
    Unit of Use DIVO694516EN0