BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3DDX Sleeve 565-465-4L

    DI: 00850073333723 · Model: Drilling template guide-sleeve /565-465-4L · 3D DIAGNOSTIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3DDX Sleeve 565-465-4L
    Primary DI
    00850073333723
    Version / Model
    Drilling template guide-sleeve /565-465-4L
    Company Name
    3D DIAGNOSTIX, INC.
    Labeler DUNS
    004512027
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-10
    Public Version
    1
    Public Version Date
    2025-09-18
    Public Version Status
    New
    Public Device Record Key
    8630c758-0700-4c01-88a3-b4120b5f2bde

    Device Description

    A small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use device.

    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
    Yes
    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
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    64371 Dental implantation drilling template guide-sleeve

    Identifiers

    Type ID
    Primary 00850073333723