BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptraSculpt

    DI: 07615208482751 · Model: 760476AN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    OptraSculpt
    Primary DI
    07615208482751
    Version / Model
    760476AN
    Catalog Number
    760476AN
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2026-03-13
    Public Version
    1
    Public Version Date
    2026-03-23
    Public Version Status
    New
    Public Device Record Key
    40d099b4-5579-4ca1-93ad-e101d48c06e8

    Device Description

    OptraSculpt Pad Assort/2x60

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KXR APPLICATOR, RESIN

    GMDN Terms

    Code Name
    41861 Dental restoration carver, resin

    Identifiers

    Type ID
    Unit of Use 07615208590494
    Primary 07615208482751