BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptraSculpt Starter Kit

    DI: DVIV683067AN1 · Model: 683067AN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    OptraSculpt Starter Kit
    Primary DI
    DVIV683067AN1
    Version / Model
    683067AN
    Catalog Number
    683067AN
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    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
    b8d8fe2d-20bc-4385-89c4-48f73376db62

    Device Description

    OptraSculpt Instrument, OptraSculpt Modelling tips

    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 DIVO683067AN0
    Primary DVIV683067AN1