BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TITANIT 5 98H14 with step

    DI: D800MEAL98S14 · Model: MEAL98S14 · ZIRKONZAHN SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TITANIT 5 98H14 with step
    Primary DI
    D800MEAL98S14
    Version / Model
    MEAL98S14
    Company Name
    ZIRKONZAHN SRL
    Labeler DUNS
    564251911
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-20
    Public Version
    1
    Public Version Date
    2022-07-28
    Public Version Status
    New
    Public Device Record Key
    fd9c7556-c7c2-4a90-b52f-f6a048da75f0

    Device Description

    Content: 1 piece Height: 14 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.

    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
    No

    Product Codes

    Code Name
    EJH ALLOY, METAL, BASE

    GMDN Terms

    Code Name
    38614 Dental bridge, metal-ceramic

    Identifiers

    Type ID
    Primary D800MEAL98S14

    Customer Contacts

    Phone
    +390474066660
    Email
    [email protected]