BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Universal Shapers

    DI: 00860014936630 · Model: Scalloping Drill SS6 · UNIVERSAL SHAPERS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Universal Shapers
    Primary DI
    00860014936630
    Version / Model
    Scalloping Drill SS6
    Company Name
    UNIVERSAL SHAPERS LLC
    Labeler DUNS
    104090226
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-06
    Public Version
    1
    Public Version Date
    2026-02-16
    Public Version Status
    New
    Public Device Record Key
    0d625b69-bed8-40cc-84d1-edb82bd377c0

    Device Description

    A specialized dental instrument used for bone profiling, shaping, and sculpting in implant dentistry. These drills are designed to create a "scalloped" or contoured bone profile around the platform of dental implants to better match the natural, anatomical shape of the bone, particularly in the esthetic zone (anterior maxilla).

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZA Drill, Dental, Intraoral

    GMDN Terms

    Code Name
    45714 Fixture/appliance dental drill bit, reusable

    Identifiers

    Type ID
    Primary 00860014936630