BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Polishers

    DI: D836TKJGX4 · Model: 1 · DENT ZAR, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Polishers
    Primary DI
    D836TKJGX4
    Version / Model
    1
    Catalog Number
    2024
    Company Name
    DENT ZAR, INC.
    Labeler DUNS
    789664455
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-08
    Public Version
    1
    Public Version Date
    2022-03-16
    Public Version Status
    New
    Public Device Record Key
    98260cb3-a438-4f26-b472-a2110fac8436

    Device Description

    A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EJR Agent, Polishing, Abrasive, Oral Cavity

    GMDN Terms

    Code Name
    31833 Dental abrasive point, reusable

    Identifiers

    Type ID
    Primary D836TKJGX4