BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Tetric

    DI: DIVO692157EN1 · Model: 692157EN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tetric
    Primary DI
    DIVO692157EN1
    Version / Model
    692157EN
    Catalog Number
    692157EN
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-27
    Public Version
    4
    Public Version Date
    2022-06-24
    Public Version Status
    Update
    Public Device Record Key
    88b5b524-19c1-47e2-970e-8adf3491363a
    Distribution End Date
    2022-06-23

    Device Description

    Tetric CAD for CEREC HT I12 A1, Tetric CAD for CEREC HT I12 A2, Tetric CAD for CEREC HT I12 A3, Tetric CAD for CEREC MT C14 A1, Tetric CAD for CEREC MT C14 A2, Tetric CAD for CEREC MT C14 A3, Variolink Esthetic DC Neutral, Adhese Universal VivaPen, OptraPol Test Pack, various accessories

    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
    EBF MATERIAL, TOOTH SHADE, RESIN

    GMDN Terms

    Code Name
    62817 Dental appliance fabrication material, combination-material

    Identifiers

    Type ID
    Primary DIVO692157EN1