BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PRO3DURE GR-17 temporary

    DI: EPRCD1001444 · Model: 500g - A1 · pro3dure medical GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    PRO3DURE GR-17 temporary
    Primary DI
    EPRCD1001444
    Version / Model
    500g - A1
    Company Name
    pro3dure medical GmbH
    Labeler DUNS
    312947842
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-18
    Public Version
    2
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    911e64d2-a814-4c55-8a01-95f5ad350d84

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    45236 Temporary dental crown/bridge resin

    Identifiers

    Type ID
    Primary EPRCD1001444

    Customer Contacts

    Phone
    +4923749200500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K201827 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    18 – 28 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight