BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptraSculpt and OptraSculpt Pad System Kit

    DI: DVIV683066AN1 · Model: 683066AN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

    Basic Information

    Brand Name
    OptraSculpt and OptraSculpt Pad System Kit
    Primary DI
    DVIV683066AN1
    Version / Model
    683066AN
    Catalog Number
    683066AN
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2020-08-26
    Public Version
    3
    Public Version Date
    2022-03-17
    Public Version Status
    Update
    Public Device Record Key
    9a90f56b-e244-40c0-83bb-08af3e81f6ea

    Device Description

    OptraSculpt Pad Instument, OptraSculpt Instrument, OptraSculpt Modelling tips, OptraSculpt Pad Modelling tips 4mm

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZN INSTRUMENTS, DENTAL HAND

    GMDN Terms

    Code Name
    41861 Dental restoration carver, resin

    Identifiers

    Type ID
    Unit of Use DIVO683066AN0
    Primary DVIV683066AN1