BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rodin

    DI: 00815967028789 · Model: 23994 · Pac-Dent, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Rodin
    Primary DI
    00815967028789
    Version / Model
    23994
    Company Name
    Pac-Dent, Inc.
    Labeler DUNS
    080104787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-23
    Public Version
    1
    Public Version Date
    2026-03-31
    Public Version Status
    New
    Public Device Record Key
    87c6f181-fbbc-42ff-9f30-218512799f4b

    Device Description

    Rodin™ Titan 3D Resin, Ceramic Nanohybrid, Shade A2, 600 g

    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary 00815967028789