BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Y-Kelin

    DI: 06943566107391 · Model: 36 Tablets · ANHUI GREENLAND BIOTECH CO.,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    36

    Basic Information

    Brand Name
    Y-Kelin
    Primary DI
    06943566107391
    Version / Model
    36 Tablets
    Company Name
    ANHUI GREENLAND BIOTECH CO.,LTD
    Labeler DUNS
    544396491
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    36
    Record Status
    Published
    Publish Date
    2022-12-06
    Public Version
    1
    Public Version Date
    2022-12-14
    Public Version Status
    New
    Public Device Record Key
    01e2bce6-e55c-4b0e-8a8a-3681128e21fe

    Device Description

    Product Name:Plaque Indicator Specification:0.3g/piece*12/box Manufacturer:Anhui Greenland Biotech Co., Ltd Address:No.5, Kaiyuan Rd,Mchekou Industrial Zone, Huaishang District,Bengbu, Anhui,China Tel:0552-5875300 Product performance:Used to show plaquue, assist oral examination and treatment Main ingredients:Erythrosine, Blue No.1 AluminumLake, Glucose, Silica, PEG-180, Magnesium Stearate, Spices Scope of application:Suitable for peoplewho are expected to show dental plaque Contraindications: 1.People who are allergic to ingredients are prohibited to use. 2.Do not swallow directly. 3.Use with caution for pregnant women and infants. Instructions: 1.Take a piece of plaque indicator into your mouth and chew it, lick it with the tip of your tongue to the inside and outside of the entire tooth surface, and hold it in your mouth for about 1 minute. 2.Spit out the residue in your mouth and rinse your mouth with water. 3. Check the oral cavity with a mirror, the stained part of the tooth surface is the part where the plaque is attached. Store: This product is stored in a ventilated and dry place at room temperature. Transportation conditions/methods:Transportation conditions and methods must meet the requirements of the instructions and signs. Period of use: Three years.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EFT Cleanser, Denture, Over The Counter

    GMDN Terms

    Code Name
    35871 Denture cleanser

    Identifiers

    Type ID
    Unit of Use 16943566107398
    Primary 06943566107391