BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SIMPLANT®

    DI: 07392532269684 · Model: 68017218 · Dentsply Implants Manufacturing GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SIMPLANT®
    Primary DI
    07392532269684
    Version / Model
    68017218
    Catalog Number
    68017218
    Company Name
    Dentsply Implants Manufacturing GmbH
    Labeler DUNS
    344038836
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-17
    Public Version
    1
    Public Version Date
    2023-07-25
    Public Version Status
    New
    Public Device Record Key
    ced4d8bf-babd-4960-86cd-88d9c0eeeee0

    Device Description

    O/Guide Sleeve 4.6 ND PrimeTaper/AstraTech Implant EV

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    Yes
    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
    57948 Dental guided surgery reference pin

    Identifiers

    Type ID
    Primary 07392532269684