BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Resin Teeth DCL PE

    DI: DIVO5248051 · Model: 524805 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Resin Teeth DCL PE
    Primary DI
    DIVO5248051
    Version / Model
    524805
    Catalog Number
    524805
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-23
    Public Version
    2
    Public Version Date
    2022-01-31
    Public Version Status
    Update
    Public Device Record Key
    6f0a7533-7b84-4d41-808b-c057bdeb20d9
    Distribution End Date
    2022-01-28

    Device Description

    SR Orthosit PE 8er UN4 1D

    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
    ELM Denture, plastic, teeth

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary DIVO5248051