BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ProVecta 3D Prime Ceph

    DI: E247A78610 · Model: A7861 · DÜRR DENTAL SE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ProVecta 3D Prime Ceph
    Primary DI
    E247A78610
    Version / Model
    A7861
    Company Name
    DÜRR DENTAL SE
    Labeler DUNS
    315563684
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-04
    Public Version
    2
    Public Version Date
    2024-01-24
    Public Version Status
    Update
    Public Device Record Key
    b8691eae-0a2c-4505-a47c-e794eef426af

    Device Description

    X-Ray System

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OAS X-Ray, Tomography, Computed, Dental

    GMDN Terms

    Code Name
    61019 Cone beam computed tomography system, head/neck

    Identifiers

    Type ID
    Primary E247A78610

    Premarket Submissions

    Submission Number Supplement Number
    K193139 000
    K232487 000