BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IDODENTINE

    DI: 08435288443461 · Model: DISC B1 95/16mm · UNION DENTAL SA
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IDODENTINE
    Primary DI
    08435288443461
    Version / Model
    DISC B1 95/16mm
    Catalog Number
    4252Z/B1
    Company Name
    UNION DENTAL SA
    Labeler DUNS
    462114760
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-09
    Public Version
    2
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    d7ad45ff-49f9-4608-a1bf-68321966e8e1

    Device Description

    IDODENTINE DISC COLOR B1 95/16mm

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBG Crown And Bridge, Temporary, Resin
    MQC Mouthguard, Prescription
    EBI Resin, Denture, Relining, Repairing, Rebasing

    GMDN Terms

    Code Name
    31783 Temporary dental crown/bridge

    Identifiers

    Type ID
    Primary 08435288443461

    Premarket Submissions

    Submission Number Supplement Number
    K150432 000