BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surgical Guide

    DI: 00850073333020 · Model: Dental Implantation Drilling Template-Custom Made Surgical Guide · 3D DIAGNOSTIX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Surgical Guide
    Primary DI
    00850073333020
    Version / Model
    Dental Implantation Drilling Template-Custom Made Surgical Guide
    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
    46d6efce-688f-4a3e-a277-575278703677

    Device Description

    Surgical Guide is intended to be used as an aid in the surgical placement of endosseous dental implants. Surgical guide allows a dental surgeon to place an implant in a very specific, pre-planned location to give the most ideal depth, angulation, and size of implant to fit the space.

    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
    63484 Dental implantation drilling template, custom-made

    Identifiers

    Type ID
    Primary 00850073333020